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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