Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION: A REVIEW

Vaishnavi Jitendra Chaudhari*1, Sunila A. Patil, Sunil P. Pawar and Sulbha G. Patil

ABSTRACT

The creation of analytical methods, followed by method validation, is a key step in the drug discovery process. Despite the drug's high potency, the lack of a certified analytical method will prevent it from reaching the market. This is to assure the drug's purity and safety. The primary goal of this study is to provide an overview of the old and new methodologies available for analysing pharmaceuticals in their raw material and formulated forms, as well as to assess drug stability in the presence of excipients and other stressors encountered during their shelf life. The study sheds emphasis on hyphenated methods such as LC-MS-MS, LCNMR- MS, GC-MS, and LC –MS for drug analysis and impurity profiling. The development of bio-analytical methods for the quantitative determination of pharmaceuticals in diverse biological matrices is also covered in this study. By dealing with SIAMs, it also gives a way to assess the biological safety of medications (stability indicating assay methods).

Keywords: Validation, Method development, HPLC.