4.
A Validated RP-HPLC Method for Simultaneous
determination of Atorvastatin and Fenofibrate in Bulk and Its
Dosage Form
Murugesan Jagadeeswaran1*, Natesan
Gopal2, Balasundaram Jayakar3, Thangavel
Sivakumar1
1Nandha College of Pharmacy, Department of
Pharmaceutical Analysis, Erode -638 052, Tamil Nadu, India
2Department of Medicinal Chemistry, Faculty of
Pharmacy, MAHSA University College, Kuala Lumpur -50490,
Malaysia
3Vinayaka Missions College of Pharmacy,Department of
Pharmaceutical Chemistry, Salem- 636 308, Tamil Nadu, India
Abstract:
A simple, specific, accurate and precise reverse phase high
pressure liquid chromatographic method has been developed
for the simultaneous determination of Atorvastatin and
Fenofibrate in tablet dosage form by reverse phase C18
column, Phenomenex (250 x 4.60 mm), Particle Size 5 µ. The
samples were analyzed by using
Acetonitrile: 0.1 % w/v Phosphoric acid in the ratio of
65:35 v/v as a mobile phase at the flow rate of 2 mL min-1
in isocratic mode and detection wavelength 254 nm. Both the
drugs were eluted within 10 minutes and give sharp peak with
high theoretical plate count and low tailing factor. The
retention time for Atorvastatin and Fenofibrate was found to
be 4.3 and 7.7 minute respectively. The
validation was carried according to ICH guidelines. In
linearity curve, correlation coefficients for Atorvastatin
and Fenofibrate were found to be 0.9987 and 0.9992
respectively. The percent recovery was 99.65 for
Atorvastatin and 99.88 for Fenofibrate indicating accuracy
and reliability of method. So the method can be used for
estimation of combination of these drugs in tablet dosage
form.
Keywords:
Atorvastatin, Fenofibrate, RP-HPLC, Tablets.
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