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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 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.

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


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