Abstract

UV SPECTROSCOPIC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF PITAVASTATIN CALCIUM AND EZETIMIBE IN COMBINED PHARMACEUTICAL FORMULATION

Patel Esha*, Dr. Zarna Dedania, Dr. Ronak Dedania and Dr. Vineet Jain

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Abstract

Introduction: A simple, rapid, accurate and economical UV spectrophotometric method for the simultaneous determination of Pitavastatin Calcium and Ezetimibe in combined Pharmaceutical formulation has been developed. Aim: The aim was to create a system that could determine both components concurrently while being selective, sensitive, and accurate. The strategy was approved in terms of Linearity, Accuracy (%recovery), Precision (Interday and Intraday), LOD, LOQ and Assay. Materials and Method: The approach is based on the use of methanol as a solvent and simultaneous equation for the study of both drug. Pitavastatin Calcium has absorbance maxima at 244.60nm and Ezetimibe has absorbance maxima at 234nm in methanol. Results: For, Pitavastatin Calcium and Ezetimibe, linearity was obtained in the concentration ranges of 1-5 μg/ml and 5-25 μg/ml, respectively. In UV r2 was estimated 0.999 for Pitavastatin Calcium and 0.997 for Ezetimibe. Intraday Precision was figured 0.35-0.80 and 0.44-0.58 for Pitavastatin calcium and 0.25-0.34 and 0.13-0.27 for Ezetimibe. Interday Precision was figured 0.27-0.78 and 0.44-0.46 for Pitavastatin calcium and 0.26-0.34 and 0.21-0.30 for Ezetimibe. Accuracy of Pitavastatin calcium was counted in the range of 98.7-101.5% and Ezetimibe was in the range of 98.3-101.3%. LOD value was deliberated 0.051 μg/ml for Pitavastatin Calcium and 0.124μg/ml for Ezetimibe. LOQ value for both drug was found to be 0.155 μg/ml and 0.375 μg/ml respectively. Assay of marketed formulation valued 98.86±0.0016 and 99.18±0.0021 of both drug.

Keywords: UV Spectrophotometry, Pitavastatin Calcium, Ezetimibe, Methanol, Validation.