Quality by design assisted high‐performance liquid chromatography parameters for simultaneous estimation of simvastatin and fenofibrate

Abstract

AbstractIn a present study quality by design was used to develop a reliable high‐performance liquid chromatography method for simultaneous estimation of simvastatin and fenofibrate. A robust chromatographic setting for quality peaks and appropriate component separation within a reasonable run duration was generated. Furthermore, to determine critical quality attributes (CQA), a quantitative relationship between critical material attributes and CQA was established using Box‐Behnken design to produce analytical design space and develop a control approach. The mathematical models used three independent characteristics, acetonitrile volume, buffer molarity, and flow rate. The optimum and expected conditions were acetonitrile and potassium dihydrogen orthophosphate buffer (pH 2.9 adjusted, with orthophosphoric acid) (80.65:19.35 v/v) as an optimized mobile phase at a flow rate of 0.99 ml/min. We achieved adequate baseline separation of both drugs in just 10 min with these optimum parameters. The amount of acetonitrile was revealed to be the most important factor determining the perturbation plot responses. The %recoveries for both medicines were 99.15%–101.86% at all three levels. Both drugs showed relative standard deviations for repeatability, and intermediate precision were less than 2%. As a result, a simple, accurate, and repeatable high‐performance liquid chromatography approach for routine quality control testing was developed.