Quality-by-Design Based Development and Validation of Stability Indicating Method by UPLC Method for Impurities of Simvastatin from Drug and Pharmaceutical Dosage Form

A rapid, robust and accurate ultra-high performance liquid chromatographic method was developed validated for determination of impurities simvastatin in drug its pharmaceutical formulation. systematic Quality-by-design approach used development with the Fusion AETM software, to screen optimize column, mobile phase, column temperature, gradient time other conditions. The optimized uses Waters Acquity Charged Surface Hybrid, Octadecylsilane C18 (1.7μm×2.1 mm×100 mm) elution. Orthophosphoric acid pH adjusted 4.5 triethylamine acetonitrile a ratio (80:20) as phase A, whereas methanol:acetonitrile (20:80) B, flow rate 0.35 ml/min. Ultra Violet detector programmed at 238 nm runtime 13 min, wherein all were well resolved separated from main peak simvastatin. accuracy, repeatability, reproducibility robustness. All validation parameters acceptable range. linearity, limit detection quantitation established also applied suitably determining degradation products using stress studies