Abstract

METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF SIMVASTATIN IN BULK AND TABLET DOSAGE FORM BY RP-HPLC

D. Snigdha*, Kusuma Pravalika, Soma Srikanth, Md. Abdul Hafeez Uddin, Chatharasi Vinay Kumar and K. Priyanka

ABSTRACT

A simple, rapid, and precise reversed-phase high-performance liquid chromatographic method for estimation Simvastatin in bulk and tablet dosage form has been developed and validated as per ICH Guidelines. Chromatographic separation was performed on a Waters ODS (C18) RP Column, 250 mm x 4.6 mm. 5μm column with Acetonitrile: Methanol (70:30) as mobile phase at a flow rate of 1.0 mL min−1. UV detection was performed at 242nm. Total run time was 6.0 minutes is eluted with retention time was found to be 3.816minutes. The method was validated for accuracy, precision, linearity, specificity, and sensitivity in accordance with ICH guidelines. Validation revealed the method is specific, rapid, accurate, precise, reliable, and reproducible. Calibration plots were linear over the concentration ranges 0–50μg mL−1 for Simvastatin. Limit of detection were 0.09μg mL−1 and limit of quantification were 0.26μg mL−1 for Simvastatin. The high recovery and low coefficients of variation confirm the suitability of the method for estimation of Simvastatin in bulk and tablet dosage form. The developed method offers several advantages in terms of simplicity in mobile phase, mode of elution, easy sample preparation steps and comparative short run time which makes the method specific and reliable for its intended use in routine analysis of estimation of Simvastatin in bulk and tablet dosage form.

Keywords: Simvastatin, Method Development, Validation, Accuracy, Precision.