Abstract

A REVIEW ON METHOD DEVELOPMENT AND VALIDATION BY RP-HPLC METHOD

S. Yuvasri*, S. Murugan and T. Vetrichelvan

ABSTRACT

High performance liquid chromatography (HPLC) is an analytical tool in appraising drug product. It is able to detect, separate and quantify the drug, impurities and drug related degradants that can form manufacturing and storage. Many chromatographic parameters were evaluated in order to optimize the method like sample pretreatment, choosing mobile phase, column and detector selection. HPLC method development depends upon chemical structure, synthetic route, solubility, polarity, pH, pka and functional group activity etc. It also involves the understanding of chemistry of drug substance and facilitates the development of the analytical method. This article mainly focuses on the optimization of HPLC conditions. A sequence of events required for method development and analytical validation are described. Validation of HPLC method as per ICH guidelines covers all performance characteristics like accuracy, precision, specificity, linearity, range, limit of detection, limit of quantification. All validation parameters are used in the analysis.

Keywords: RP-HPLC, instrumentation, method development, validation.