ABSTRACT

Understanding the important components and their interplay effects by conducting a desired set of experiments has lately acquired prominence in the field of analytical method development. As a result, this study discusses the QbD approach to RP-HPLC method development utilising Design of Experiments, as well as the technique's validation for analysis. HPLC is an analytical method that is capable of separating, detecting, and quantifying different pharmaceuticals and their associated degradation products. Separating produced pharmaceuticals from drug-related impurities, detecting and quantifying synthesised drugs, and reducing other contaminants during separation are all uses of this technique that are commonplace. Analyses were carried out to determine the best chromatographic parameters for the procedure. Drugs and impurities must be compatible and stable in a mobile phase that is compatible with a column, column temperature, wavelength and gradient. Analysis technique development is vital, and this study discusses the significance of RP-HPLCs and their methodologies, as well as a short understanding of key chromatographic parameters. Keywords: Quality by design approach, RP-HPLC, Validation, Development
Publication date: 25/01/2022

https://ijbpas.com/pdf/2022/January/MS_IJBPAS_2022_JAN_SPCL_2_2013.pdf

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https://doi.org/10.31032/IJBPAS/2022/11.1.2013