RESUMEN
The quality pioneer Dr. Joseph M. Juran first proposed the idea of quality by design. According to him, pharmaceutical quality by design is an organised approach to product development that starts with predetermined goals and places an emphasis on product, process understanding, control based on reliable science and quality risk management. The quality of a product or process can typically be affected by a number of input elements. Design of experiments has been employed widely recently to understand the impacts of multidimensional and interactions of input parameters on the output responses of analytical procedures and pharmaceutical goods. Depending on the design of experiments objectives, screening, characterization, or optimization of the process and formulation, a variety of designs, such as factorial or mixture, can be used. The most popular designs used in the stage of screening or factor selection are the 2-Level Factorial and Plackett-Burman designs, both of which have two levels for each factor (k), both economical and effective, and in optimization widely used designs in this step are full factorial at three levels, central composite, Box-Behnken design. The analysis of variance, regression significance, and lack of fit of the regression model were some of the key topics covered in the discussion of the main components of multiple regression model adjustment. Design of experiments is thus the primary element of the formulation and analytical quality by design. The details about design of experiments used for the analysis of pharmaceutical formulation using HPLC.
Asunto(s)
Gestión de Riesgos , Cromatografía Líquida de Alta Presión/métodos , Preparaciones FarmacéuticasRESUMEN
Major issues in the pharmaceutical industry involve efficient risk management and control strategies of potential genotoxic impurities (PGIs). As a result, the development of an appropriate method to control these impurities is required. An optimally sensitive and simultaneous analytical method using gas chromatography with a mass spectrometry detector (GC-MS) was developed for 19 alkyl halides determined to be PGIs. These 19 alkyl halides were selected from 144 alkyl halides through an in silico study utilizing quantitative structure-activity relationship (Q-SAR) approaches via expert knowledge rule-based software and statistical-based software. The analytical quality by design (QbD) approach was adopted for the development of a sensitive and robust analytical method for PGIs. A limited number of literature studies have reviewed the analytical QbD approach in the PGI method development using GC-MS as the analytical instrument. A GC equipped with a single quadrupole mass spectrometry detector (MSD) and VF-624 ms capillary column was used. The developed method was validated in terms of specificity, the limit of detection, quantitation, linearity, accuracy, and precision, according to the ICH Q2 guideline.