METHOD DEVELOPMENT AND VALIDATION OF OLANZAPINE BY UPLC METHODS FOR PHARMACEUTICAL DOSAGE FORM

Abstract

The aim of current research was to develop and validate a new very rapid, sensitive, Ultra Performance LiquidChromatography (UPLC) technique for the estimation of Olanzapine in dosage form, as there is no official monograph 8 no analytical method by UPLC. Different chromatographic column and different mobile phase composition were tried to optimise the method. Liquid chromatography (LC) was carried out on a Waters Acquity UPLC with a photodiode array detector (DAD/PDA). The output signal was monitored and processed using empowers 2 software. The chromatographic column used was Acquity UPLC BEH C-18 (100-mm, 2.1-mm, and 1.7-µm) particle sizes. The flow rate of the mobile phase was 0.36 mL/min. The developed method was validated according to the International Conference on Harmonization (ICH) guidelines with respect to linearity, accuracy, precision, specificity and robustness. The developed method was linear for Olanzapine from 10-50 μg/ml and the linear regression obtained was > 0.999. Precision, evaluated by intra- and inter-day assays had relative standard deviation (R.S.D) values within 1.5 %. Recovery data were in the range 98.2 % to 100.9 % with R.S.D. values less than 1.5 %. The method is precise, accurate, linear, robust and fast. The short retention time of 2.433 min allows the analysis of a large number of samples in a short period of time and, therefore, should be cost-effective for routine analysis in the pharmaceutical industry.