Reverse Phase-High Performance Liquid Chromatography method development and validation for estimation of efavirenz by Quality by Design approach

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 by using software (design expert 8). The present study describes the development of a comprehensive science and risk based HPLC method which is given by design expert 8 and subsequent validation for the analysis of Efavirenz active pharmaceutical ingredient (API) using a quality by design approach. An efficient experimental design based on systematic scouting of all four key components of the RP‐HPLC method (column, pH, mobile phase and flow rate) is presented. The described method was linear. R2=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 Efavirenz. The proposed method can be used for routine analysis of Efavirenz in quality control laboratories. Keywords: Quality by design, HPLC, Efavirenz, design expert 8