Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF OLANZAPINE IN FORMULATED PRODUCT

Navya Khandelwal, Tapeesh Bharti*, Chatrasal Singh Rajput and R P S Rathore

Abstract

A novel approach was carried out to develop and validate a rapid and selective analytical method by using Reverse Phase Ultra Performance Liquid Chromatographic (RP-UPLC) technique for the analysis of Olanzapine in raw materials, their pharmaceutical dosage forms. The developed analytical UPLC method is superior in technology to conventional HPLC method with respect to speed, resolution, solvent consumption and cost of analysis. Elution time for the separation was 3.5 min in reverse phase mode and ultra violet detection was carried out at 254 nm. Efficient separation was achieved on Water Acquity BEH C18 column (50 × 2.1 mm, 1.7μm) UPLC column using 0.1% v/v TFA and acetonitrile as organic solvent in a gradient. The olanzapine sample was first dissolved in ethanol and the final dilution done by using water:acetonitrile (50:50 v/v) as diluent. The method showed excellent recoveries for all drugs in bulk. The test solution was found to be stable in diluent for 72 h when stored at RT (i.e 25 oC) . Recovery data were in the range 96.74 to 101.35%. The developed UPLC method was validated with respect to linearity, precision, accuracy, stability and specificity. The method was economical in terms of the time taken and the amount of solvent used. To the best of our knowledge, a validated reverse phase analytical method for the analysis of olanzapine by using UPLC technique disclosed in this investigation was not published elsewhere.

Keywords: Olanzapine, UPLC, new method development, validation.