Abstract

QbD APPROACH FOR DEVELOPMENT OF STABILITY INDICATING RP - HPLC METHOD AND IT’S VALIDATION: A REVIEW

Ajay Chaudhary*, Alka N. Choudhary and Kamlesh K. Dutta

Abstract

Untill a few years ago, the quality of drug products were mostlydetermined by purity rather than impurities. But the things has changedand the quality of drug products are now determined by not only puritybut also the impurities/degradants present in them. Regulatory bodiesare now more concerned on impurities along with purity because of thehealth concern. It is therefore necessary to develop scientifically soundmethod that is capable to separate, detect and quantify the drug -related degradants that can form on storage or manufacturing of thedrug product and any drug – related impurities that may be introducedduring synthesis of the drug. RP-HPLC is the most powerful anddominant analytical technique available in todays world for thepurpose. Here in this review is presented a step-by-step QbD approachto for developing stability indicating RP-HPLC method and its validation. Methoddevelopment, validation and its life cycle management must incorporate in it the concept ofQbD and QRM.

Keywords: Quality by Design, Stability Indicating, RP - HPLC, Method Development and Validation, Force Degradation, Gradient Scouting.