QbD APPROACH FOR DEVELOPMENT OF STABILITY INDICATING RP - HPLC METHOD AND IT’S VALIDATION: A REVIEW
Journal Title: World Journal of Pharmaceutical Research - Year 2018, Vol 7, Issue 5
Abstract
Untill a few years ago, the quality of drug products were mostly determined by purity rather than impurities. But the things has changed and the quality of drug products are now determined by not only purity but also the impurities/degradants present in them. Regulatory bodies are now more concerned on impurities along with purity because of the health concern. It is therefore necessary to develop scientifically sound method that is capable to separate, detect and quantify the drug - related degradants that can form on storage or manufacturing of the drug product and any drug – related impurities that may be introduced during synthesis of the drug. RP-HPLC is the most powerful and dominant analytical technique available in todays world for the purpose. Here in this review is presented a step-by-step QbD approach to for developing stability indicating RP-HPLC method and its validation. Method development, validation and its life cycle management must incorporate in it the concept of QbD and QRM.
Authors and Affiliations
Ajay Chaudhary
Keywords
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