Rp-HPLC Method Development and Validation for Simultaneous Estimation of Atorvestatin Calcium and Fenofibrate in Bulk and Formulation
Swapnil Balwant Deshmukh
*
D.C.S’s A.R.A College of Pharmacy, Nagaon, Dhule, India.
Ravindra Banilal Patil
D.C.S’s A.R.A College of Pharmacy, Nagaon, Dhule, India.
*Author to whom correspondence should be addressed.
Abstract
A reverse phase high performance liquid chromatographic method was developed for the simultaneous determination of atorvastatin and Fenofibrate in bulk and pharmaceutical dosage forms. The determination was performed by using Waters Symmetry C18 (250×4.6mm×5µ) as column stationary phase and Methanol: Acetonitrile: Water in the ratio of (70:10:20 %v/v) as mobile phase. The flow rate of mobile phase was optimized as 1mL/min and effluents were monitored at 274 nm. The retention time of atorvastatin and Fenofibrate were found as 4.15 min and 8.10 min respectively. The method shows linearity concentration ranges between 4-30 μg/mL and 80-400 μg/mL respectively. The developed method was validated for specificity, precision, linearity, accuracy, robustness, Ruggedness, LOD and LOQ. Recovery of atorvastatin and Fenofibrate in formulations was found to be 100.52% and 99.92% respectively which conforms the non-interferences of the excipients in the formulation. the proposed RP- HPLC method can be used for the simultaneous determination of these two drugs in bulk and formulation.
Keywords: Atorvastatin calcium, validation, fenofibrate, robustness