DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF OLANZAPINE IN MARKETED FORMULATION

A simple, accurate, precise and rapid stability indicating RP-HPLC method was developed and validated for the analysis of Olanzapine in marketed formulation. Analysis was performed on a C-18 (250mm x 4.60mm, 5 µm) column as stationary phase and using mobile phase which was Potassium di-hydrogen phosphate Buffer (pH 6): Acetonitrile (60:40) (v/v) at a flow rate of 1ml/min with UV detection at 258 nm at constant room temperature. The injection volume was 20 µl and the chromatographic runtime of 5 min was used. Proposed method was found to be linear in the range of 5-25 μg/ml with the correlation coefficient 0.998. The validation and the reliability of proposed method were assessed by recovery study. The recovery of added standards (80%, 100% 120%) was ranging from 99.58% - 100.50%. The robustness of developed method was checked by changing temperature, flow rate and mobile phase ratio