Method Validation and Method Development by using Analytical Method- HPLC- Review on Current Research

Abstract

Analytical method development is should be validated to give proper data for regulatory submission. High performance liquid chromatography (HPLC) is very useful in the drug discovery, manufacturing process, and development of pharmaceutical materials. It is also useful to separate manufacturing drugs from drug substance impurities, for detection and quantify the synthetic drugs and it reduce rest impurities at the time of the separation. It is also need to ensure that safety and quality of drugs. Validation is the method of use to the performance characteristic and its limitation of method and its identification of the influence that may replace these characteristics. This review described the planning and the problems pertinent to designed High performance liquid chromatography (HPLC) development of method and method validation. The force degradation studies useful in method validation and method development of stability indicating analytical method.