応用薬学ジャーナル
オープンアクセス

概要

DEVELOPMENT OF UV SPECTROPHOTOMETRIC METHODS AND VALIDATION FOR ESTIMATION OF SIMVASTATIN IN BULK AND TABLET DOSAGE FORM BY ABSORBANCE MAXIMA AND AREA UNDER THE CURVE METHOD

Vinit Chavhan, Kavya Reddy, Kashmira Ahhirao

Introduction: To develop two simple UV spectrophotometric methods for simultaneous estimation of Simvastatin (SMV) in bulk and tablet dosage form and validate as per ICH guidelines. Methods: Method A involved Absorbance maxima method which based on the measurement of absorbance of Simvastatin in methanol at λmax of Simvastatin 238 nm and Method B involved Area under the curve (AUC) method which based on the measurement of AUC in the range of 234-240 nm. Results: The developed methods were validated for linearity, precision, accuracy, LOD and LOQ as per ICH guidelines. Both the methods were found to be linear within the conc. range of 4-32 μg/ml for Simvastatin. Conclusion: The present methods were found to be simple, linear, precise, accurate and sensitive and can be used for routine quality control analysis for the estimation of Simvastatin in bulk and tablet dosage form.