A simple, precise, specific and reproducible HPTLC method is described for the simultaneous quantification of Atorvastatin calcium, Fenofibrate and Ezetimibe in a ternary mixture. The method was based on separation of three drugs on Merck aluminium plates precoated with silica gel 60 F254 using Toluene: methanol: acetone: triethylamine (7:2:1:0.2 v/v) as mobile phase. Quantitative analysis was performed by densitometric scanning at 252 nm. The three drugs were satisfactorily resolved with Rf values of 0.21, 0.79 and 0.42 mins for Atorvastatin calcium, Fenofibrate and Ezetimibe respectively. The developed method was validated for linearity, accuracy, precision, robustness and specificity studies as per the ICH guidelines. The method was found to be linear over concentration ranges of 200-1200 ng/μl, 50-300 ng/μl and 100-350 ng/μl for Atorvastatin calcium, Fenofibrate and Ezetimibe respectively. Recovery studies indicated accurate recoveries of the three drugs using standard addition method. The % RSD values for the intra-day and inter-day precision studies were found to be 1.25, 1.75 and 1.44 and 1.22, 1.72 and 1.46 for Atorvastatin calcium, Fenofibrate and Ezetimibe respectively. The HPTLC method was successfully applied to the analysis of all the three drugs in a pharmaceutical tablet formulation. No chromatographic interference from the tablet excipients was seen in this method. The acid degraded solutions of Atorvastatin calcium, Fenofibrate and Ezetimibe, when applied along with pure API’s did not showed any interference from peaks of degradation products.
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