A Concise Review on HPLC Method Development and Validation

Author(s)

Gupta, D., Singh, B.K.

Author's Affiliation

Abstract

HPLC is an analytical tool which is able to detect, separate and quantify the drug, its various impurities and drug related degradants that can form on synthesis or storage. HPLC method development and validation play important role in new discovery, development and manufacture of pharmaceutical drugs. An analytical procedure is developed to test a defined characteristic of the drug substance or drug product against established acceptance criteria for that characteristic. A number of chromatographic parameters were evaluated in order to optimize method. This review gives information regarding various stages involved in development and validation of HPLC method. Validation of HPLC method as per ICH guidelines covers all the performance characteristics of validation.

Keywords

HPLC, Validation, Method development, Degradants

Cite This Article

Gupta, D., Singh, B.K. (2016). A Concise Review on HPLC Method Development and Validation, International Journal for Pharmaceutical Research Scholars (IJPRS), 5(3), 160-166.