RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF OLANZAPINE AND FLUOXETINE IN TABLET DOSAGE FORM
Journal Title: Int J of Pharm Res & Analy - Year 2014, Vol 4, Issue 4
Abstract
A new precise, accurate, reliable validated method for the determination of Olanzapine and Fluoxetine has been developed by using reverse phase high performance liquid chromatography (RP-HPLC) in pharmaceutical dosage form. Chromatographic separation was carried out by using mobile phase 0.01M Phosphate buffer PH 5.8: Acetonitrile (55:45v/v, PH-2.6 adjusted with Orthophosphoric acid) on HYPERSIL ODS C18 (250 x 4.6 mm, 5) at a flow rate 1ml/min with UV detection at 261nm.The retention times for Olanzapine and Fluoxetine were 3.480 and 2.597 min respectively and both drugs showed good linearity in the range of 18-42μg/ml and 72-168μg/ml. The proposed method has been successfully applied to marketed formulation and was validated according to ICH guidelines and method showed good precision with percentage relative standard deviation less than 2%. The percentage recovery for Olanzapine and Fluoxetine was found between 100.3 and 99.3 respectively indicating the proposed method was accurate and precise.
Authors and Affiliations
V. Pranitha , R. Saraswathi, , Uma Maheshwar Rao V , Ajitha A
Keywords
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- EP ID EP122778
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