SIMULTANEOUS ESTIMATION OF ROSUVASTATIN CALCIUM AND CLOPIDOGREL BISULPHATE FROM BULK AND COMMERCIAL PRODUCTS USING A VALIDATED REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC TECHNIQUE
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2012, Vol 3, Issue 11
Abstract
A simple, rapid, accurate, precise and economical reverse phase high performance liquid chromatographic method is developed for simultaneous separation and quantification of two cardiovascular drugs, viz., Rosuvastatin Calcium and Clopidogrel Bisulphate. The separation of both the drugs was achieved on Novapak C18 column (100 x 3.9 mm, 4 µm) column using a mobile phase of Sodium Perchlorate buffer solution (at pH 2.5): Acetonitrile (65:35 v/v). The flow rate was 1 ml/min and detection was done at 242 nm. The retention time for Rosuvastatin Calcium was 4.4 min and Clopidogrel Bisulphate was 7.6 min. Rosuvastatin Calcium and Clopidogrel Bisulphate showed a linear response in the concentration range of 10-60 µg/ml and 18.75 - 112.5 µg/ml respectively. The correlation co-efficients for Rosuvastatin Calcium and Clopidogrel Bisulphate were 0.9999 and 0.9999 respectively. The percentage recoveries obtained for Rosuvastatin Calcium and Clopidogrel Bisulphate ranges from 99.1% to 100.5% and 99.1% to 99.6% respectively. The results of analysis have been validated as per ICH guidelines. Validation results indicated that method shows satisfactory linearity, accuracy, precision and ruggedness. The extremely low flow rate, simple mobile phase composition makes this method cost effective, rapid, non-tedious and can also be successfully employed for simultaneous estimation of both drugs in commercial products.
Authors and Affiliations
Avani Sheth, K N Patel, Badmanaban Ramlingam, Nehal Shah
Keywords
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