Abstract

A REVIEW ON METHOD DEVELOPMENT AND VALIDATION

Jyoti Patel*, Dr. Sunila Patil and Dr. Sunil Pawar

ABSTRACT

Analytical method development followed by method validation is an important process in the drug discovery. Although the drug shows good potency, lack of validated analytical method will not allow the drug to enter into the market. This is to ensure the quality and safety of the drug. The main objective of this review is to give an idea about the old and novel techniques available for the analysis of drugs in their raw material and formulated forms, check the stability of the drugs in the presence of the excipients and other stress conditions experienced during their shelf life period. The review work puts a light on the hyphenated techniques for the analysis and impurity profiling of drugs like LC-MS-MS, LC- NMR-MS, GC-MS and LC –MS. This review also deals with the method development for the quantitative determination of the drugs in the various biological matrices. It also provides a means to determine the biological safety of the drugs by dealing with the SIAMs (stability indicating assay methods).

Keywords: Validation, Stability indicating, Impurity, bioanalytical, HPLC, HPTLC.