DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR QUANTIFICATION OF SIMVASTATIN IN TABLET
Dharavath. Pannalal*, Deepthi P, Purushothaman M
KLR Pharmacy College, Paloncha, Bhadradri Kothagudem, Telangana-507511, India
The present study successfully developed and validated a rapid, precise, and accurate RP-HPLC method for the quantification of Simvastatin in bulk and tablet formulations, following ICH guidelines. Systematic optimization of chromatographic parameters, including mobile phase composition, stationary phase, flow rate, and detection wavelength, was performed to achieve sharp, symmetrical peaks with minimal tailing and excellent resolution. The method demonstrated high specificity, with no interference from tablet excipients, as indicated by clear separation of the Simvastatin peak from blank solutions. Linearity was observed over the range of 1–6?ppm, with a correlation coefficient (R²) of 0.999, confirming proportional detector response to analyte concentration. Precision studies showed intraday R.S.D. of 0.435% and interday R.S.D. of 1.033%, both well within the acceptable limit of 2%, indicating high reproducibility. Accuracy, assessed by the standard addition method, yielded recoveries between 99.0% and 100% with mean R.S.D. of 0.248%, confirming the method’s reliability for quantitative analysis.System suitability parameters were within acceptable limits, with tailing factors <2 and theoretical plates >2000, ensuring adequate column efficiency and peak symmetry. Sensitivity assessment showed a limit of detection (LOD) of 0.05?ppm and a limit of quantification (LOQ) of 0.165?ppm, demonstrating the method’s ability to detect and quantify even trace amounts of Simvastatin. Overall, the optimized RP-HPLC method is simple, rapid, and reproducible, making it suitable for routine quality control of Simvastatin in bulk and tablet formulations. Its precision, accuracy, linearity, robustness, and sensitivity ensure reliable quantification and support consistent quality assurance in pharmaceutical analysis.
15 , 2 , 2025
89 - 97