Development and validation of a method for simultaneous densitometric analysis of simvastatin and ezetimibe as the bulk drugs and in the tablet dosage form
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Simvastatin is a selective HMG-CoA reductase inhibitor and ezetimibe has lipid-lowering activity. Both are potential anti-lipidemic agents used in combination to reduce the amount of cholesterol and triglycerides in systemic circulation. This paper describes a simple, precise, and accurate HPTLC method for simultaneous estimation of the compounds as the bulk drugs and in the tablet dosage form. Chromatographic separation was performed on aluminium-backed silica gel 60 F254 plates with 8:2 (v/v) toluene- 2-propanol as mobile phase. The separated spots were densitometrically evaluated at 240 nm. The drugs were satisfactorily resolved with RF values 0.48 š 0.01 and 0.53 š 0.01 for simvastatin and ezetimibe, respectively. The accuracy and reliability of the method were assessed by determination of validation data for linearity (0.4-2.0 µg per spot for both simvastatin and ezetimibe), precision (intra-day RSD 0.51-1.04%, inter-day RSD 0.34-1.11% for simvastatin; intra-day RSD 0.47-0.61%, inter-day RSD 0.31-0.61% for ezetimibe), accuracy (98.50 š 0.23 for simvastatin and 98.99 š 0.38 for ezetimibe), and specificity, in accordance with ICH guidelines. The proposed method can be used for analysis of ten or more formulations on a single plate and is a rapid and cost-effective quality-control tool for routine simultaneous analysis of simvastatin and ezetimibe as the bulk drugs and in tablet formulations.
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