RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF ATORVASTATIN AND EZETIMIBE IN PHARMACEUTICAL DOSAGE FORM
Journal Title: Asian Journal of Pharamceutical and Clinical Research - Year 2015, Vol 8, Issue 2
Abstract
 Objective: The aim was to develop a simple, selective, linear, precise, and accurate reverse phase high performance liquid chromatography methodfor simultaneous estimation of atorvastatin and ezetimibe in tablet dosage form.Methods: The chromatographic separation was performed using hypersil BDS C18 coloumn (250 mm × 4.6 mm, 5 mm particle size). Mobile phasecomposed of phosphate buffer pH-4.5 and acetonitrile (35:65 v/v) at a flow rate of 1 ml/min. Detection was carried out using photodiode arraydetector at 228 nm. The method was validated as per ICH guidelines.Results: The retention time for atorvastatin and ezetimibe are observed as 2.36 and 3.43 minutes respectively. Linearity range was observed inconcentration of 12.5-75 μg/ml for both atorvastatin and ezetimibe. The percentage recoveries of atorvastatin and ezetimibe are 100.21% and100.22% respectively. The correlation coefficients for both the components are close to 1.Conclusion: This method is simple, selective, linear, precise, accurate and sensitive hence can be successfully employed for the routine quality controlof dosage forms containing both the drugs in pharmaceutical industries.Keywords: Reverse transcription polymerase chain reaction, Method development, Atorvastatin, Ezetimibe, Validation.
Authors and Affiliations
Saroj Kumar Raul, Ratna Bhaskar Aravelli, Durgasi Jhansi
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