Analytical Method Development in Pharmaceutical Research:Steps Involved in HPLC Method Development

High performance liquid chromatography (HPLC) has proven to one of the major analytical technique used in the qualitative and quantitative analysis of drugs worldwide. Majority of drugs prescribed in official pharmacopoeias are being analyzed HPLC. Method development and validation is the essential part in the drug development programme in pharmaceutical industries and are associated with various steps such as pre-formulation, formulation, production, quality control and quality assurance and marketing of pharmaceutical products. Analytical method development is complicated process which takes time from few hours to months. This review paper covers the basic practical aspects of HPLC and gives guidance on how to develop HPLC analytical methods. This review provides the brief introduction, need and various steps involved in HPLC analytical method development.