ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF OLANZAPINE BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

Abstract

Objective of the study was to develop and validate a new rapid, sensitive, reverse phase High Performance Liquid Chromatography technique for the estimation of Olanzapine in bulk and dosage form. Chromatographic separation was achieved on a BDS Hypersil C18, (150 mm × 4.6 mm, 5μm) with a mobile phase of 0.01M Tetra butyl ammonium hydrogen sulphate: Methanol (60:40) v/v. The flow rate was 1.0 ml/min, temperature of the column was maintained at ambient and detection was made at 228 nm. The run time was as short as 10.0 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 - 80μg/ml and the linear regression obtained was 0.9994. Recovery of Olanzapine was found to be in the range of 99.6 -101.7%. Precision, evaluated by intra- and inter-day assays had relative standard deviation (R.S.D) values within 1.0 %. The ruggedness of the method was validated by performing the analysis by two different analysts and no significant difference in the result was found. Robustness of the method was checked by varying flow rate by 0.2 ml/min and the result was not affected significantly. The analysis of the marketed sample indicated that the method can also be applied to dosage form successfully. The method is precise, accurate, linear, robust and fast. The retention time and run time was very short; hence it is cost effective, making it more economical and rapid. Hence, this method can be used for the analysis of large number of samples.