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1.
Ann Pharm Fr ; 2024 Aug 31.
Artículo en Inglés | MEDLINE | ID: mdl-39222709

RESUMEN

OBJECTIVE: To develop and validate a rapid, accurate, economical, effective and greenery RP-HPLC method for the determination of Zolmitriptan in tablet dosage form. MATERIAL AND METHOD: RP-HPLC method was developed using Luna (C18) (4.6×250mm, 5µm) column and Sodium phosphate buffer (pH 4.7): Methanol [75: 25, v/v] was used as mobile phase at a flow rate of 1.0mL/min. The detection was carried out at 227nm. Further, eco-friendliness, productivity and performance of the optimized analytical method were assessed by green and white tools. RESULTS: The retention time of Zolmitriptan was found to be 3.25min with acceptable chromatographic parameters. The optimized RP-HPLC method was more eco-friendly, efficient, throughput and practicable than the reported methods as confirmed by AES, AGREE, GAPI and RGB tools. Further, the proposed analytical method showed all the validation parameters within the acceptance limit of ICH Q2 R1 guidelines. The linear regression analysis indicated a good linear response in the 10 to 120µg/mL concentration range with R2 of 0.99998. The percentage content and percentage assay of Zolmitriptan in Zomig-5mg tablet was found to be 103.36±0.356% and 97.86±0.693%. CONCLUSION: The developed and validated method has several advantages compared to the reported HPLC methods and is useful in the systematic analysis of Zolmitriptan in its dosage form.

2.
Talanta ; 281: 126856, 2024 Sep 10.
Artículo en Inglés | MEDLINE | ID: mdl-39260250

RESUMEN

A molecularly imprinted polymer (MIP) has been synthetized, characterized, impregnated on paper, and integrated into a 3D printed platform with smartphone-based fluorescent detection for the determination of tetracycline in water samples. The MIP synthesis was performed by precipitation polymerization, which was subsequently deposited onto a glass microfiber paper. The synthesized polymer and the MIP@paper have been characterized by FTIR spectroscopy, scanning electron microscopy, and EDS spectroscopy. Afterward, a 3D printed detection platform that houses monochromatic LED strips as radiation source and a smartphone as detector have been used for determination of tetracycline. Digital image processing was based on the RGB colour model using image J software and the red intensity channel was used as analytical signal due to its higher sensitivity. Several factors that affect the adsorption capacity and fluorescent detection have been optimized. Under optimum conditions, detection limit of 0.04 mg L-1 and good linearity up 5 mg L-1 (r = 0.998), were achieved. The intra- and inter-day precision of 4.9 and 7.2 %, respectively, expressed as relative standard deviation (%RSD) were obtained, showing the good precision of the proposed methodology. Satisfactory recoveries between 87 and 98 % were obtained spiking real water sample matrices at different concentrations (0.1-0.3 mg L-1). The portable 3D platform with smartphone-based fluorescent detection exploiting all-in-one spot test method for tetracycline using MIP@paper was evaluated with AGREE and GAPI metrics, evidencing its environmentally friendly approach. Furthermore, the BAGI tool demonstrated the practicality of the method, in terms of functionality and applicability compared to previous HPLC and spectrofluorometric methods.

3.
Antioxidants (Basel) ; 13(8)2024 Aug 20.
Artículo en Inglés | MEDLINE | ID: mdl-39199258

RESUMEN

Supply chain waste gives rise to significant challenges in terms of disposal, making upcycling a promising and sustainable alternative for the recovery of bioactive compounds from by-products. Lignocellulosic by-products like STF231, which are derived from the medicinal plant extract industry, offer valuable compounds such as polyphenols and iridoids that can be recovered through upcycling. In an unprecedented study, we explored and compared conventional hydroethanolic extraction, ultrasound hydroethanolic extraction, and natural deep eutectic solvents-ultrasound extraction methods on STF231 to obtain extracts with antioxidant activity. The extraction profile of total polyphenols (TPCs) was measured using the Folin-Ciocalteu test and the antioxidant capacity of the extracts was tested with FRAP and DPPH assays. HPLC-UV was employed to quantify the phenolic and iridoid markers in the extracts. Additionally, the sustainability profile of the process was assessed using the green analytical procedure index (GAPI), AGREEprep, and analytical GREEnness metric approach (AGREE) frameworks. Our findings indicate that a choline chloride and lactic acid mixture at a 1:5 ratio, under optimal extraction conditions, resulted in extracts with higher TPC and similar antioxidant activity compared with conventional hydroethanolic extracts. The innovative aspect of this study lies in the potential application of sustainable upcycling protocols to a previously unexamined matrix, resulting in extracts with potential health applications.

4.
Pharmaceuticals (Basel) ; 17(8)2024 Jul 29.
Artículo en Inglés | MEDLINE | ID: mdl-39204107

RESUMEN

A cost-effective, selective, sensitive, and operational TLC-densitometric approach has been adapted for the concurrent assay of Hydroxyzine Hydrochloride (HYX), Ephedrine Hydrochloride (EPH), and Theophylline (THP) in their pure powder and pharmaceutical forms. In the innovative TLC-densitometric approach, HYX, EPH, and THP were efficaciously separated and quantified on a 60F254 silica gel stationary phase with chloroform-ammonium acetate buffer (9.5:0.5, v/v) adjusted to pH 6.5 using ammonia solution as a mobile liquid system and UV detection at 220 nm. The novel TLC method validation has been performed in line with the international conference for harmonization (ICH) standards and has been effectively used for the estimation of the researched medicines in their pharmaceutical formulations without intervention from excipients. Additionally, parameters affecting the chromatographic analysis have been investigated. The new TLC approach's functionality and greenness were appraised using three modern and automated tools, namely the Blue Applicability Grade Index (BAGI), the Analytical Greenness metric (AGREE), and the Green Analytical Procedure Index (GAPI) tools. In short, the greenness characteristics were not achieved as a result of using mandatory, non-ecofriendly solvents such as ammonia and chloroform. On the contrary, the applicability and usefulness of the novel TLC approach were attained via concurrent estimation for the three drugs using simple and straightforward procedures. Moreover, the novel TLC method outperforms previously published HPLC ones in terms of the short run time per sample and moderate pH value for the liquid system. According to the conclusions of comparisons with previously recorded TLC methods, our novel HPTLC method has the highest AGREE score, so it is the greenest HPTLC strategy. Moreover, its functionality and applicability are very appropriate because of the simultaneous assessment of three drugs in one TLC run. Furthermore, no tedious and complicated extraction and evaporation processes are prerequisites.

5.
J AOAC Int ; 2024 Jul 18.
Artículo en Inglés | MEDLINE | ID: mdl-39024015

RESUMEN

BACKGROUND: Intestinal coccidiosis is a debilitating disease in poultry and livestock, leading to economic impact worldwide. Coccidiosis is prevented and treated in broilers by the inclusion of anticoccidials in feed. Toltrazuril is administered in potable water to treat coccidiosis. OBJECTIVE: Three robust analytical methods for quantitation of toltrazuril in pure and pharmaceutical formulations are developed. Furthermore, ecological metrics; either penalization- or color-code-based techniques are applied for the appraisal of assays. METHODS: Firstly, Second-Derivative (Δλ; 5 nm) spectrophotometric method; Toltrazuril is measured from peak to peak at 244-260 nm within a linearity range of 5-25 µg/mL. The second one is a high-performance thin-layer chromatography (HPTLC) analysis performed on an aluminum sheet of silica gel using ethyl acetate, methanol, ammonium chloride buffer, and water (8:1:0.5:0.5) (%V/V) as the elution phase. Toltrazuril, at a retardation factor of 0.66 ± 0.01, is linearly determined in the range of 1-9 µg/spot at 243 nm. The third one is Reversed Phase-HPLC-diode array detection, using Agilent column C18 (5 µm, 4.6 x 150 mm) in isocratic elution mode with a mobile phase of acetonitrile and water in a ratio of 80:20 (v/v), respectively, at 1 mL/min flow rate. Toltrazuril elutes at a retention time of 2.58 ± 0.1 min and is linearly determined at 243 nm in the range of 0.25-25 µg/mL. RESULTS: Calculated 2D-values and peak areas are highly correlated to their corresponding drug concentrations at coefficients; r > 0.999. All methods were ICH validated and applied to dosage form with satisfactory % recoveries (97-103%). Statistical comparisons reported one using t-test and F-test disclose insignificant variation. Examining greenness and whiteness norms, proposed methods were evaluated and ranked alongside four different reported methods. CONCLUSION: The proposed methods are green, accurate, and can be applied in routine quality control for the determination of toltrazuril in pharmaceutical formulations.

6.
BMC Chem ; 18(1): 131, 2024 Jul 15.
Artículo en Inglés | MEDLINE | ID: mdl-39010206

RESUMEN

A fast eco-friendly colorimetric method was developed for the determination of Tobramycin in drug substance, ophthalmic formulations, and spiked human plasma using silver nanoparticles optical sensor. Even though tobramycin is non-UV-visible absorbing, the developed method is based on measuring the absorbance quenching of silver nanoparticles resulting from the interaction with tobramycin. Different factors affecting the absorbance intensity were studied as; silver nanoparticle concentration, pH, buffer type, and reaction time using quality by design approach. Validation of the proposed method was performed according to ICH guidelines and was found to be accurate, precise, and sensitive. The linearity range of tobramycin was 0.35-4.0 µg/mL. The optical sensor was successfully applied for the determination of Tobramycin in ophthalmic formulations and spiked human plasma without pre-treatment. Additionally, the binding between Tobramycin and PVP- capped silver nanoparticles was studied using molecular docking software. The method was assessed and compared to colorimetric reported methods for the green character using Green Analytical Procedure Index (GAPI) and Analytical GREEnness calculator (AGREE) tools and found to be greener.

7.
Luminescence ; 39(3): e4710, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-38481364

RESUMEN

A simple and facile microwave-assisted method was developed for the synthesis of highly fluorescent nitrogen-doped carbon quantum dots (N-CQDs) using sucrose and urea. The produced quantum dots exhibited a strong emission band at 376 nm after excitation at 216 nm with quantum yield of 0.57. The as-prepared N-CQDs were characterized using Fourier-transform infrared (FTIR) spectroscopy, transmission electron microscopy (TEM) images, and ultraviolet-visible (UV-visible) spectra. The average particle size was 7.7 nm. It was found that torsemide (TRS) caused an obvious quenching of the fluorescent N-CQDs; so, they were used for its spectrofluorometric estimation. An excellent linear correlation was found between the fluorescence quenching of N-CQDs and the concentration of the drug in the range of 0.10 to 1.0 µg/mL with limit of quantitation (LOQ) of 0.08 µg/mL and limit of detection (LOD) of 0.027 µg/mL. The method was successfully applied for the assay of the drug in its commercial tablets and spiked human plasma samples, and the results obtained were satisfactory. Complex GAPI was used for greenness assessment of the analytical procedures and the pre-analysis steps. Interference likely to be introduced from co-administered drugs was also studied.


Asunto(s)
Puntos Cuánticos , Humanos , Puntos Cuánticos/química , Torasemida , Carbono/química , Nitrógeno/química , Urea , Sacarosa , Colorantes Fluorescentes/química
8.
J Sep Sci ; 47(2): e2300757, 2024 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-38286731

RESUMEN

A new green micellar liquid chromatographic method has been developed and validated for the simultaneous determination of diphenhydramine (DPH) and tripelennamine hydrochloride (TRP) using a micellar mobile phase consisting of 1 mM Tween 20 in phosphate buffer pH 4:isopropanol (85:15, %v/v). The method was linear in the range of 4-150 and 5-120 µg/mL for TRP and DPH, respectively. The method was successfully applied for the simultaneous determination of DPH and TRP in a laboratory-prepared gel containing all possible excipients with mean percent recoveries ± standard deviation of 100.346 ± 1.265 and 100.754 ± 1.117 for TRP and DPH, respectively. The method was validated according to the International Conference on Harmonization guidelines. The method is confirmed to have excellent greenness.


Asunto(s)
Difenhidramina , Tripelenamina , Difenhidramina/análisis , Micelas , Cromatografía Liquida/métodos , Indicadores y Reactivos , Cromatografía Líquida de Alta Presión/métodos
9.
Spectrochim Acta A Mol Biomol Spectrosc ; 309: 123844, 2024 Mar 15.
Artículo en Inglés | MEDLINE | ID: mdl-38198995

RESUMEN

Metformin is considered as type 2 diabetes first line treatment according to American Diabetes Association and European Association. But, in some cases, di- or tri - therapy should be prescribed for glycemic management, prevention of the maximum dose side effects and induced effectiveness. Co-administration of Linagliptin with metformin has many benefits on diabetic patients such as decrease the possibility of hypoglycemia. For the first time, novel and reliable techniques were developed and verified for the concurrent quantification of metformin hydrochloride and linagliptin, while accounting for the existence of metformin toxic impurity 1-cyanoguanidine in their pure and dosage forms. Method (A) utilizes the zero-order spectrophotometric approach to quantitatively determine the concentration of linagliptin. The measurements are performed at a wavelength of 295 nm. The double divisor derivative ratio spectrophotometric method is used in Method (B) to measure the amounts of metformin and cyanoguanidine at 252 nm and 219 nm wavelengths, respectively. The spectrophotometric method (C) for determining metformin and cyanoguanidine at 252 nm and 223 nm, respectively, is based on the single divisor derivative ratio-zero crossing technique. The obtained findings were subjected to statistical comparison with the reported method, revealing no statistically significant differences. The Green Analytical Procedure Index (GAPI) and Analytical GREEnness Metric approach (AGREE) determined that these approaches had a high degree of environmental friendliness. Additionally, the proposed strategy was deemed to be practical according to the Blue Applicability Grade Index (BAGI) assessment tool.


Asunto(s)
Diabetes Mellitus Tipo 2 , Guanidinas , Metformina , Humanos , Metformina/análisis , Linagliptina/análisis , Hipoglucemiantes/análisis , Diabetes Mellitus Tipo 2/tratamiento farmacológico
10.
MethodsX ; 11: 102437, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37928107

RESUMEN

A new, simple, and sensitive FIA-spectrophotometric method has been developed for evaluating pure amoxicillin and pharmaceutical formulations. The FIA method involves the reaction of dapsone with sodium nitrite and hydrochloric acid. Subsequently, the diazotized dapsone is coupled with amoxicillin in an alkaline medium, resulting in a stable orange dye with a maximum wavelength of 440 nm. The developed method was validated according to the ICH guidelines and found to have a concentration range of 1-150 µg/mL, a correlation coefficient of 0.9994, a molar extinction coefficient of 0.273 × 104 L/mol.cm, and a detection limit of 0.074 µg/mL. The FIA method was then evaluated using AES, GAPI, and AGREES analytical greenness assessment tools. The FIA method uses dapsone as an eco-friendly reagent, in addition to the FIA method's advantages of reduced sample and reagent usage, reduced waste generation, and cheaper equipment. So, it has been proposed as an excellent eco-friendly method for the determination of AMX in pharmaceutical formulations.

11.
Crit Rev Anal Chem ; : 1-14, 2023 Nov 03.
Artículo en Inglés | MEDLINE | ID: mdl-37922128

RESUMEN

The main difficulties when analyzing pharmaceutically active compounds (PhACs) in solid environmental samples is the complexity of the samples and the low concentration levels of such pollutants. Most efforts are focused in achieving good analytical performance parameters such as high recoveries or low detection limits without considering if the methods are environmentally friendly. In this work, the main tools proposed for assessing the greenness of analytical methodologies (Analytical Eco-scale, Green Analytical Procedure Index (GAPI), and Analytical GREEnness metric (AGREE)) have been applied to nine analytical procedures that include recent important analytical tendencies. The three metrics identified the paper spray ionization method as the greenest procedure since it used untreated samples for direct mass spectrometry analysis. Using Analytical Eco-scale, most of the evaluated procedures were rated as "acceptable green". However, the use of internal standards resulted key in the environmental impact of the method which provided contradictory results versus other metrics. GAPI found greenness similarities between most of selected methods, hindering a greenness classification. AGREE allowed the weighting of each evaluation criterion providing a greenness ranking. The application of each metric detecting their weaknesses and strengths was discussed. The incorporation of validation analytical features in greenness metrics was a gap revealed.

12.
Curr Pharm Des ; 29(31): 2442-2449, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37877508

RESUMEN

BACKGROUND: The release of a product in the consumer market requires an analysis by quality control. This sector makes use of reliable analytical methods, by high performance liquid chromatography (HPLC), spectrophotometry in the ultraviolet and visible regions (UV-Vis), spectrophotometry in the infrared region (IR) or thin layer chromatography (TLC), for example, to reach a result. The analysis conditions of most of these analytical methods currently still use toxic reagents, generate a greater amount of waste, sample preparation has more steps, the need for instrumentation and consumables in greater quantity, generating a cost and impact on health and the environment greater than if there were adoption of the Green Analytical Chemistry (GAC) and the White Analytical Chemistry (WAC). OBJECTIVE/METHODS: The objective of this review is to show the relationship of analytical choices for current pharmaceutical analyzes with the GAC and the WAC. RESULTS: Analytical methods can be evaluated for greenness and whiteness using tools such as the National Environmental Method Index (NEMI), Eco-Scale Assessment (ESA), Analytical Greenness Metric (AGREE) and Green Analytical Procedure Index (GAPI). CONCLUSION: The use of NEMI, ESA, AGREE and GAPI tools brings the objective evidence needed to discuss the greenness and whiteness of an analytical method, leaving the subjective level. Furthermore, semi or quantitative data facilitate the choice of an analytical method and its conditions, when the target is the concern with eco-efficiency.


Asunto(s)
Cromatografía Líquida de Alta Presión , Humanos , Cromatografía en Capa Delgada , Control de Calidad , Espectrofotometría
13.
BMC Chem ; 17(1): 100, 2023 Aug 17.
Artículo en Inglés | MEDLINE | ID: mdl-37592319

RESUMEN

Considering the green chemistry perspective and improving the environmental impact of quality control labs; two direct techniques with less hazardous solvents, less waste production and less energy consumption were developed for simultaneous analysis of Aspirin and Metoclopramide in bulk powder and pharmaceutical formulation. The ratio between the two drugs in their co-formulated preparation is very challenging; (90: 1, Aspirin: Metoclopramide). The first technique is spectrophotometry using simple mathematical operations; ratio difference and derivative ratio-zero crossing. The second technique is high-performance thin-layer chromatography (HPTLC) -densitometry which used a mobile phase consisting of cyclo-hexane: methanol: methylene chloride in a ratio of (1:4:1, v/v/v). The greenest solvents which give acceptable resolution were chosen. Following the International Conference on Harmonization (ICH) guidelines, the methods were found to be accurate, precise, and selective. Those methods were statistically compared to the reported spectrophotometric method and the results proved that there is no significant difference in accuracy and precision. Furthermore, the developed methods were assessed using the Analytical Eco-scale, Green Analytical Procedure Index (GAPI) and the Analytical Greenness calculator (AGREE), which gave a full image about their greenness profile. The spectrophotometry was found to be an excellent green technique compared to HPTLC with was considered an acceptable green one. The developed HPTLC-densitometric method was used for the first time for the analysis of this binary mixture. The two proposed spectrophotometric methos have advantages over the published methods as they used easy manipulation steps and are applied on the market pharmaceutical formulation. Owing to the advantages of the developed techniques; being green, do not require expensive sophisticated equipment or large volume of solvents; they could be used for routine analysis in quality control aspects.

14.
F1000Res ; 12: 341, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37593362

RESUMEN

Background: Tigecycline (TGC) is a recently developed antibiotic to battle resistant bacteria. The procedures outlined in the literature for analyzing TGC involve chemical solvents that could be hazardous. Therefore, this study aimed to create a sustainable and stable HPLC technique for quantifying Tigecycline in lyophilized powder. The powerful chemometric tool, experimental design (ED), will be applied to analyze the variables' interaction and impact on the selected analytical target profiles. Response surface methodology provides a tutorial on using the central composite design with three levels of variables and quadratic programming to optimize the design space of the developed method. Methods: The New HPLC method consisted of an aqueous buffer and ethanol as a green mobile phase run on a reversed-phase symmetry C18 column. A full resolution between the Tigecycline and its degradation product peaks was achieved in a short analytical runtime. Results: Further, the specificity, accuracy, precision, robustness and stability indicating power of the proposed approach were verified through stress degrading testing. Conclusions: Finally, the analytical eco-scale and the green Analytical Procedure Index (GAPI) were utilized to determine how environmentally friendly the recommended method was compared to other published approaches.


Asunto(s)
Antibacterianos , Etanol , Tigeciclina , Cromatografía Líquida de Alta Presión/métodos , Agua
15.
Methods Appl Fluoresc ; 11(4)2023 Jul 26.
Artículo en Inglés | MEDLINE | ID: mdl-37459863

RESUMEN

A facile, simple, green and sensitive spectrofluorometric method was developed for determination of the calcimimetic drug cinacalcet hydrochloride. It is used for the treatment of hyperparathyroidism. The drug showed high native fluorescence intensity at 320 nm after excitation at 280 nm. The method was linear over the range of 5.0-400.0 ng ml-1with excellent correlation (R2= 0.9999). Limit of detection (LOD) and limit of quantitation (LOQ) values were 1.19 and 3.62 ng ml-1, respectively. The percentage recovery was found to be 100.42% ± 1.39 (n=8). The proposed method was successfully applied for determination of cinacalcet in spiked human plasma samples with % recoveries of (87.23 to 109.69%). Two recent greenness metrics (GAPI and Analytical Eco-Scale) were chosen to prove the eco-friendly nature of the method. Furthermore, the proposed method was successfully applied to dissolution study of commercial cinacalcet tablets. The interference likely to be introduced by some commonly co-administrated drugs such as metoprolol and itraconazole was studied; the tolerance limits were calculated.


Asunto(s)
Comprimidos , Humanos , Cinacalcet , Límite de Detección
16.
BMC Chem ; 17(1): 64, 2023 Jun 22.
Artículo en Inglés | MEDLINE | ID: mdl-37349827

RESUMEN

In addition to its pure form, three accurate, rapid, and simple methods have been established for determining perindopril (PRD) in its tablet form. At pH 9.0 using a borate buffer, developing the three designated methods was successful according to the reaction between PRD and 4-chloro-7-nitrobenzo-2-oxa-1,3-diazole (NBD-Cl) and the formation of a chromogen (with a yellow color) measurable at 460 nm using the spectrophotometric method (Method I). In addition, the produced chromogen was assessed using the spectrofluorimetric method (Method II) at 535 nm following excitation at 461 nm. Afterward, the same reaction product was separated and determined using the HPLC method with fluorescence detection (Method III). A Promosil C18 stainless steel column (Q7 5 mm particle size, 250-4.6 mm) has proven suitable for separation. The mobile phase adjustment was made at pH 3.0, with a 1.0 mL min -1 flow rate; its composition was methanol-sodium dihydrogen phosphate, 0.02 M (60: 40, v/v). Through concentration ranges of 5.0-60.0, 0.5-6.0, and 1.0-10.0 µg mL-1, the calibration curves were rectilinear for Methods I, II, and III, respectively, with limits of quantification (LOQ) of 1.08, 0.16 and 0.19 µg mL-1 as well as limits of detection (LOD) of 0.36, 0.05 and 0.06 µg mL-1. The developed methods were implemented to estimate PRD in tablets, and a comparison between the obtained outcomes utilizing the developed methods as well as obtained from the official method revealed that they were comparable. The official BP method was based on dissolving PRD in anhydrous acetic acid and titrating with 0.1 M perchloric acid, then the potentiometric determination of the end-point. The designated methods were also implemented in content uniformity testing with satisfying results. The reaction pathway proposal was speculated, and according to ICH Guidelines, the statistical evaluation of the data was performed. The three proposed methods were confirmed to be green, eco-friendly and safe to environment using Green Analytical procedure index (GAPI) method.

17.
BMC Chem ; 17(1): 62, 2023 Jun 20.
Artículo en Inglés | MEDLINE | ID: mdl-37340490

RESUMEN

Statin-associated muscle symptoms are considered as obvious adverse effects of prolonged statin therapy such as myopathy, myalgia, and rhabdomyolysis. These side effects are associated with vitamin D3 deficiency and can be adjusted by amendment of serum vitamin D3 level. Green chemistry aims to decrease the harmful effects of analytical procedures. Here we have developed a green and eco-friendly HPLC method for the determination of atorvastatin calcium and vitamin D3. The two drugs were separated in less than 10 min on Symmetry column C18 (100 × 4.6 mm, 3.5 µm) using a mixture consisting of 0.1% ortho-phosphoric acid (OPA) (pH = 2.16) and ethanol as the mobile phase in gradient manner. We have used Green Analytical Procedure Index (GAPI) tools and the Analytical GREEnness Metric Approach (AGREE) for assessment of the greenness of our proposed method. The method proved linearity over concentration ranges of (5-40) and (1-8) µg/ml with low limit of detection of 0.475 and 0.041 µg/ml for atorvastatin calcium and vitamin D3 respectively. The method was successfully validated in accordance with ICH instructions and utilized for determination of the drugs of interest either in pure form or in their pharmaceuticals.

18.
Heliyon ; 9(4): e15260, 2023 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-37123917

RESUMEN

The cutting-edge combination of aspirin (ASA) and sildenafil citrate (SIC) has been presented as a suggested dosage form for the treatment of thin endometrium and erectile dysfunction, particularly in patients with cardiovascular diseases. However, ASA is highly sensitive to degradation into its major deterioration product, known as salicylic acid (SA). Consequently, it is eminently essential to evolve approaches for the synchronous quantification of ASA and SIC in the presence of SA. The main objective of this work is to develop three approaches for the synchronous quantification of ASA and SIC in the presence of SA in their commixtures and suggested formulations without any prior separation. Three green UV-methods were employed for the synchronous quantification, namely: Dual Wavelength in Ratio Spectra (DW-RS), Advanced Amplitude Centering (AAC), and Double Divisor of Ratio Difference Derivative (DDRD-D1). In DW-RS and AAC two-wavelength manipulation was used for resolution, while in DDRD-D1 only an appropriate wavelength for the synchronous quantification of the triplex commixture was used. All approaches can be able to resolve the highly interfering spectrum of the three components presented in the triplex commixture. Good linearity was inspected in the range of 20.0-100.0, 5.0-50.0, and 4.0-60.0 µg/mL for the ASA, SIC, and SA, respectively. All developed approaches have been advocated in accordance with ICH guidelines. All results from these approaches are presented and statistically reconciled with the proclaimed HPLC method, with no considerable differences. Furthermore, the approaches' eco-friendliness was predestined by Analytical Greenness (AGREE), and the complex GAPI. Moreover, the sustainability of the used solvent was evaluated by Green Solvents Selecting Tool (GSST); in addition, the greenness of the solvent was evaluated by Greenness Index tool with a spider diagram. The suggested UV-methods may be employed for routine quality control studies of the suggested formulations ASA & SIC since they were considered sustainable, economical, and effective.

19.
J Chromatogr Sci ; 61(10): 907-917, 2023 Dec 13.
Artículo en Inglés | MEDLINE | ID: mdl-37032124

RESUMEN

Recently, the aim of analytical community is to reduce the usage of hazardous chemicals; so eco-friendly, rapid, selective and cost-effective methods were developed for simultaneous determination of montelukast sodium (MKT) and loratadine (LRT). The first method was based on chromatographic separation performed on precoated silica gel 60 GF254 plates with ethyl acetate-ethanol 9: 1 (v/v) as the mobile phase. The developed plates were scanned and quantified at 260 nm. The method gives linear correlation over concentration ranges of 0.3-3.6 µg/spot and 0.2-4.0 µg/spot for MKT and LRT, respectively. It was also successfully applied to analysis of both drugs in their pharmaceutical preparation and human plasma. The other methods are UV-spectrophotometric methods based on smart spectra manipulating to zero order spectrum of each drug. These methods are named response correlation (RC), a-centering and ratio derivative methods. RC and a-centering methods were dependent on the presence of an isosbestic point between the overlapped spectra of both drugs. While ratio derivative method based on manipulation of the ratio spectra of both drugs. The two drugs obey Beer-Lambert law over the concentration ranges of 3.0-30.0 µg/mL in the three spectrophotometric methods. Moreover, the greenness of the developed methods is assessed using suitable analytical Eco-Scale and Green Analytical Procedure Index.


Asunto(s)
Loratadina , Quinolinas , Humanos , Loratadina/análisis , Espectrofotometría/métodos , Quinolinas/análisis , Densitometría/métodos
20.
BMC Chem ; 17(1): 13, 2023 Mar 10.
Artículo en Inglés | MEDLINE | ID: mdl-36899439

RESUMEN

Molnupiravir is the first oral direct-acting antiviral prodrug recently approved for the COVID-19 pandemic. Here and for the first time, we present a novel, sensitive, robust, and simple silver-nanoparticles spectrophotometric technique for molnupiravir analysis in its capsules and dissolution media. This spectrophotometric technique involved silver-nanoparticles synthesis through a redox reaction between the reducing agent (molnupiravir) and the oxidizing agent (silver nitrate) in presence of polyvinylpyrrolidone as a stabilizing agent. The produced silver-nanoparticles have an intense surface plasmon resonance peak at 416 nm where the measured absorbance values were utilized for the quantitative analysis of molnupiravir. The produced silver-nanoparticles were recognized by using the transmission electron microscope. Under optimal conditions, a good linear rapport was accomplished between molnupiravir concentrations and the corresponding absorbance values in a range of (100-2000) ng/mL with a detection limit of 30 ng/mL. Greenness assessment was implemented using eco-scale scoring and GAPI disclosing the excellent greenness of the suggested technique. The suggested silver-nanoparticles technique was authenticated according to recommendations of the ICH and statistically assessed with the reported liquid chromatographic method without significant differences regarding accuracy or precision. Accordingly, the suggested technique is deemed a green and cheap alternative for assaying molnupiravir due to its reliance primarily on water. Furthermore, the suggested technique's high sensitivity can be employed for investigating molnupiravir bioequivalence in future studies.

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