International Journal of Pure and Applied Chemistry (IJPAC)

 

8. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Simvastatin, Ezetimibe and Fenofibrate in Ternary Mixtures


Deepak Kumar Jain*, Pratibha Patel, Sanchit Rajawat and H.S. Chandel


*Truba Institute of Pharmacy, Karond Gandhi Nagar Bypass Road, Bhopal, M.P – 462036 (India)
Deepak Kumar Jain (Asst. Prof) Truba Institute of Pharmacy, Karond Gandhi Nagar Bypass Road, Bhopal (M.P.)–462036(India). Tel: +919424036795,
E-mail: jaindeepak2081@yahoo.com 

Abstract: A simple, precise, rapid and accurate reversed-phase liquid chromatographic method has been developed for the simultaneous estimation of Simvastatin, Ezetimibe and Fenofibrate in their ternary mixture form. Chromatographic separation achieved isocratically on Luna C18 column (5 µm, 150mm x 4.60mm) and acetonitrile/ammonium acetate buffer (75:25, v/v, pH 4.5) as mobile phase, at a flow rate of 1 mL/min. Detection was carried out at 240 nm. Parameters such as linearity, precision, accuracy, recovery, specificity and ruggedness are studied as reported in the ICH guidelines. The retention time of Ezetimibe, Simvastatin and Fenofibrate was found to be 2.41, 7.55 and 9.88 min respectively. The linear dynamic ranges were from 2-10, 2-10 and 32-160 µgmL-1 for Ezetimibe, Simvastatin and Fenofibrate respectively. The percentage recovery obtained for Ezetimibe, Simvastatin and Fenofibrate were 98.78, 97.25 and 98.38%, respectively. The correlation coefficients for all components are close to 1. The relative standard deviations for three replicate measurements in three concentrations of samples in tablets are always less than 2%. The developed method can be used for routine quality control analysis of titled drugs in combination in tablet formulation.

 

Key Words: Ezetimibe, Simvastatin, Fenofibrate, RP-HPLC, Simultaneous Estimation
 

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