Abstract

A simple, rapid, accurate, precise and reproducible simultaneous RP-HPLC method for the estimation of Olanzapine and Fluoxetine in bulk and tablet dosage form was developed and validated as per ICH guidelines. The separation was done using BDS Eqisil C18 250 x 4.6 mm, 5 µ column. The mobile phase (Phosphate Buffer pH 4.9 and Acetonitrile 50:50% v/v) was pumped at 1.0ml/min and effluent was detected at 233nm using a UV detector. The retention times for Fluoxetine and Olanzapine were 3.641 ± 0.1 min and 6.3332 ± 0.1 min and the method produced a linear response in the concentration range of 2-20 µg/ml for Fluoxetine and 5-30 µg/ml for Olanzapine (r2 - 0.999). In recovery studies, % RSD from reproducibility was found to be below 2%. LOD and LOQ were 0.726 µg/ml and 2.2 µg/ml for Fluoxetin and 1.056 µg/ml and 3.2 µg/ml for Olanzapine respectively. The developed RP-HPLC method was found to be effective, sensitive and specific for the simultaneous estimation of Fluoxetine and Olanzapine in bulk and tablet dosage form.

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