Quantitative determination of ademetionine in tablets utilizing ATR-FTIR and partial least squares methods approaches.
J Pharm Biomed Anal
; 241: 115991, 2024 Apr 15.
Article
en En
| MEDLINE
| ID: mdl-38301577
ABSTRACT
In this study there were utilized a combination of Fourier transform infrared spectroscopy in attenuated total reflection mode (ATR-FTIR) and partial least squares (PLS) regression method to develop quantitative models for determining the concentration of ademetionine in commercial tablets. The established and validated models were specifically designed for a commercial product containing ademetionine 1,4-butandiesulfonate. The coefficient of determination for the developed model was 0.999. Relative standard deviation (RSD) does not exceed 1.6% for repeatability and intermediate accuracy, which meets the international ICH and AOAC requirements for the method performance. The validation results effectively confirmed that this method is suitable and meets the current requirements for analytical methods in drug quality control. Consequently, this approach can be used for routine ademetionine analysis in pharmaceutical products and has the potential to be applied to other active pharmaceutical ingredients (APIs) in drug quality control.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
S-Adenosilmetionina
Idioma:
En
Revista:
J Pharm Biomed Anal
Año:
2024
Tipo del documento:
Article
Pais de publicación:
Reino Unido