Abstract

THE SECRETS REVIEW OF RAPID HPLC METHOD DEVELOPMENT AND VALIDATION

Singh Gurcharan*, Sethi Reeta, Setia Anupama, Lakhotra Surinder and Rathi Sudeep

ABSTRACT

Analytical method development and validation assume fundamental part in the drug discovery, Drug advancement and assembling the pharmaceutical products. It include identification of the purity and toxicity of a drug substance. High performance liquid chromatography might be used as the reason of choices and identifying with controlling the medication to patients, play important roles and functions in new revelation, advancement, production of drugs and different examinations identified with humans and animals. Various chromatographic parameters have been assessed so as to improve the techniques in the examination of strategy advancement in HPLC. An appropriate mobile phase, column, column temperature, wavelength, and gradient are developed. This review gives data with respect to different stages engaged with advancement and approval of HPLC technique. Approval of HPLC method according to ICH Guidelines covers all the exhibition qualities of validation like Accuracy, precision, specificity, linearity, range and limit of detection, limit of quantification, robustness and system suitability testing.

Keywords: HPLC, Chromatography, Method Development, Method Validation, ICH, Regulatory Requirment.