Abstract

METHOD DEVELOMENT AND VALIDATION BY HPLC FOR PHARMACUETICAL ANALYSIS: A CONCISE REVIEW

Kalyani Bhongade*, Shailesh Jawarkar, Madhuri Game and Jagruti Dolas

ABSTRACT

Many different strategies of high performance liquid chromatographic method development are used today. This review describes a strategy for the systematic development of High performance liquid chromatographic (HPLC) methods. High performance liquid chromatography is most accurate methods widely used for the qualitative and quantitative analysis of drug product. It involves detection of the purity and toxicity of a drug substance. A number of chromatographic parameters were evaluated in order to optimize the method. An appropriate mobile phase, column, column temperature, wavelength and gradient must be found that affords suitable compatibility and stability of drug as well as degradants and impurities. Validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose. The parameters described here are according to ICH guidelines and include accuracy, precision, specificity, and limit of detection, limit of quantitation, linearity, range, ruggedness and robustness. The objective of this paper is to review the method development, optimize method parameters and validation of method for drug product from developmental stage of formulation to commercial batch of product.

Keywords: HPLC, method development, validation, Qualitative, Quantitative, ICH guidelines.