Development and Validation for Simultaneous Estimation of Rosuvastatin Calcium and Clopidogrel Bisulfate in Pharmaceutical Dosage Form by Reverse Phase-High Performance Liquid Chromatography (Research Article)

Author(s): Awdhut Pimpale* and Rajendra Kakde

Abstract: Aim: The present work was focused on the development and validation of reversed phase high performance liquid chromatography (RP-HPLC) method which is simple, rapid, precise, accurate, sensitive, and economical for the quantification of rosuvastatin calcium and clopidogrel bisulfate in bulk and tablet formulation. Methods: The separation was attained on reversed phase Princeton (C18) column with dimensions (250×4.6 mm, 5μ) employing buffer which is mixture of water (pH 3.0, adjusted with ortho phosphoric acid) and methanol in the ratio (20:80) v/v as mobile phase, at flow rate 1.0 ml/min and detection was carried out at wavelength 240nm. The retention time under optimized condition of rosuvastatin calcium and clopidogrel bisulfate was found to be 2.844 min and 4.388 min respectively. Results: The linearity of the method was demonstrated in the concentration range of 6-16 μg/ml and 45-120 μg/ml for rosuvastatin calcium and clopidogrel bisulfate with a correlation coefficient (r2) of 0.9999 and 0.9996 respectively. The percentage relative standard deviation was ˂2% and percentage recovery was found to be 100.12-101.37% and 99.72-101.09% for rosuvastatin calcium and clopidogrel bisulfate respectively. Assay of marketed tablet formulations was found to be 98.99% and 99.92% respectively. Conclusion: The developed RP-HPLC method was found to be simple, specific, sensitive, rapid, linear, accurate, precise and economical and could be used for regular quality control of rosuvastatin calcium and clopidogrel bisulfate in bulk and tablet formulations.

PAGES: 296-303  |  85 VIEWS  188 DOWNLOADS