Development of UV Spectrophotometric Method and Estimation of Simvastatin in Tablet Formulation

A simple, precise, accurate, and cost-effective UV–visible spectrophotometric method for simvastatin was developed and validated in accordance with ICH Q2 (R1) guidelines. The maximum absorbance wavelength (λmax) of simvastatin was determined to be 238 nm. The range of the calibration curve was between 1-20 µg/mL, and absorbance values were recorded at 238 nm to generate a calibration curve, yielding a correlation coefficient of 0.999. The calculated limit of detection (LOD) and limit of quantitation (LOQ) were 0.11406 µg/mL and 0.34565 µg/mL, respectively. The method demonstrated acceptable accuracy, precision, robustness, and ruggedness when evaluated with quality control standards. This validated method is suitable for the estimation of simvastatin in bulk drug and plant extract samples. The method demonstrated acceptable accuracy, precision, robustness, and ruggedness when evaluated with quality control standards. It was successfully applied for the estimation of simvastatin in bulk drug and commercial tablet formulations. Keywords: UV-method, Simvastatin, Zocor, Tablet Estimation, Validation.