Stability Indicating Hptlc Method Development And Validation For Simultaneous Estimation Of Rosuvastatin Calcium And Ezetimibe In Bulk Form And Pharmaceutical Formulation
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Abstract
Validated stability indicating high performance thin layer chromatography method has been developed for simultaneous estimation of Rosuvastatin calcium (ROS) and Ezetimibe (EZT) in bulk and pharmaceutical dosage form. The stationary phase consists of Silica Gel G 60 F254 and mobile phase consists of Toluene: Methanol: Ethyl acetate: Formic acid (8:2:1:0.01v/v/v/v) and detection was carried out at 245 nm. The Rf values of ROS and EZT were found to be 0.28 ±0.02 and 0.48 ±0.02 respectively. Validation of method was carried out as per ICH guidelines. Good linear relationship was found with the calibration curve for linearity in the concentration range of 300-800ng/spot and 300-800ng/spot for ROS and EZT with r2 value 0.9997 and 0.999 respectively. For ROS and EZT the LOD was found to be 92ng/spot and 100ng/spot respectively. The LOQ value for ROS and EZT was found to be280ng/spot and 300ng/spot respectively. % recovery for ROS was found to be 98.46% to 102.1% and for EZT was found to be 99.6% to 100%. Both drugs have been exposed to the acidic, basic, neutral, oxidative, photolytic and thermal conditions for forced degradation studies. The degradation products obtained from degradation studies were resolved from the principle drug peak with different Rf values.
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References
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