Stability Indicating RP-HPLC Method for Simultaneous Determination of Simvastatin and Ezetimibe from Tablet Dosage Form

A simple, specific and sensitive reverse phase high performance liquid chromatographic method was developed and validated for simultaneous determination of ezetimibe and simvastatin from pharmaceutical dosage forms. The method uses C18 ODS Hypersil column and isocratic elution. The mobile phase comp...

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Bibliographic Details
Published in:Indian journal of pharmaceutical sciences 2010-03, Vol.72 (2), p.204-210
Main Authors: Dixit, R P, Barhate, C R, Padhye, S G, Viswanathan, C L, Nagarsenker, M S
Format: Article
Language:English
Subjects:
Accuracy
Analytical chemistry
Chromatography
Dosage and administration
High performance liquid chromatography
Methods
Noise
Pharmaceuticals
Properties
Research Paper
Simvastatin
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Summary:A simple, specific and sensitive reverse phase high performance liquid chromatographic method was developed and validated for simultaneous determination of ezetimibe and simvastatin from pharmaceutical dosage forms. The method uses C18 ODS Hypersil column and isocratic elution. The mobile phase composed of acetonitrile:phosphate buffer (pH 4.5, 0.01M) in the ratio of 65:35 v/v was used at a flow rate of 1.0 ml /min. UV detector was programmed at 232 nm for first 10 min and at 238 nm for 10 to 20 min. All the validation parameters were in acceptable range. The developed method was effectively applied to quantitate amount of ezetimibe and simvastatin from tablets. The method was also applied suitably for determining the degradation products of ezetimibe and simvastatin.
ISSN:0250-474X
1998-3743
DOI:10.4103/0250-474X.65028