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Method Development and Validation of Olanzapine in Pure and Pharmaceutical Dosage form by Rp-Hplc Method

Mastiholimath V.S.*, Dandagi P.M., Gadad A.P., Murali Krishna N.V.and Mannur V.

Department of Quality Assurance KLE University’s College of Pharmacy Belgaum-590 010, Karnataka, India.




A simple and reliable reverse phase high-performance liquid chromatography method was developed and validated for Olanzapine in pure and pharmaceutical dosage form. The method was developed on BDS Hypersil C18, (150 mm x 4.6 mm, 3μm) with a mobile phase of 0.01M tetra butyl ammonium hydrogen sulphate : methanol (80:20 v/v). The effluent was monitored by SPD-M20A, prominence UV-VIS detector at 234 nm. Calibration curve was linear over the concentration range of 10 –60μg/ml For interday and intraday precision % relative standard deviation values were found to be 0.18% and 0.24% respectively. Recovery of olanzapine was found to be in the range of 99.93 -100.00%. The limit of detection (LOD) and quantitation (LOQ) were 0.39275 and 1.1901μg/ml, respectively. The retention time and run time was very short; hence it is cost effective, making it more economical and rapid. Also this method can be used for the analysis of large number of samples.

Year 2013 | Volume No. 50 | Issue No.2 | Page No. 20-26
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