Analytical method development and validation for simultaneous estimation of olanzapine and fluoxetine in pure and pharmaceutical dosage form by using RP-HPLC
Keywords:Olanzapine, Fluoxetine, RP-HPLC, Validation.
A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Olanzapine and Fluoxetine, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Phenomenex Gemini C18 (4.6 x 150mm, 5µm) column using a mixture of Methanol: Water (90:10) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 240 nm. The retention time of the Olanzapine and Fluoxetine was 2.256, 5.427 ±0.02min respectively. The method produce linear responses in the concentration range of 5-25µg/ml of Olanzapine and 25-125µg/ml of Fluoxetine. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of pure and pharmaceutical formulations.