"QbD APPROACH TO ANALYTICAL RPHPLC METHOD DEVELOPMENT AND ITS VALIDATION

Abstract

Quality by design (QbD) refers to the achievement of certain predictable quality with desired and predetermined specifications. A very useful component of the QbD is the understanding of factors and their interaction effects by a desired set of experiments. The present study describes the development of a comprehensive science and risk based HPLC method and subsequent validation for the analysis of zidovudine active pharmaceutical ingredient (API) using a quality by design approach. An efficient experimental design based on systematic scouting of all three key components of the RP‐HPLC method (column, pH and mobile phase) is presented. The described method was linear. (r(2)=0.9998). The precision, ruggedness and robustness values were also within the prescribed limits (<1% for system precision and <2% for other parameters). Chromatographic peak purity results indicated the absence of co‐eluting peaks with the main peak of zidovudine.The proposed method can be used for routine analysis of zidovudine in quality control laboratories.