RP-HPLC Method Development and Validation for the Simultaneous estimation of Simvastatin and Ezetimibe in Tablet Dosage Form
Journal Title: International Journal of Pharmacy and Analytical Research - Year 2014, Vol 3, Issue 1
Abstract
A simple reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for simultaneous determination of Simvastatin and Ezetimibe in pharmaceutical tablet dosage form. Chromatographic analysis was performed on a Symmetry C8 (4.6mm x 150mm, 5m) column at ambient temperature with a mixture of ortho phosphoric acid buffer and Acetonitrile in the ratio 40:60 v/v (Ortho phosphoric acid buffer preparation; Take 1000ml of HPLC grade water and 1 ml orthophosphoric acid and pH adjusted) as mobile phase, at a flow rate of 1.0 mL min-1. UV detection was performed at 221 nm. The method was validated for accuracy, precision, specificity, linearity and sensitivity. The retention times of Simuvastatin and Ezetimibe were 2.190 and 3.515 min, respectively. Calibration plots were linear over the concentration ranges 10–50 μg mL-1 and 10-50 μg mL-1 for Simvastatin and Ezetimibe, respectively. The Limit of detection was 2.0 and 6.31µg mL-1 and the quantification limit were 6.31 µg mL-1 and 2.99 µg mL-1 for Simvastatin and Ezetimibe, respectively. The accuracy of the proposed method was determined by recovery studies and found to be 99.98% to 101.21%..
Authors and Affiliations
Mohammed. Ibrahim
Keywords
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- EP ID EP656066
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