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ISRN Analytical Chemistry
Volume 2014 (2014), Article ID 616941, 6 pages
http://dx.doi.org/10.1155/2014/616941
Research Article

Isocratic High-Performance Liquid Chromatographic Assay of Olanzapine: Method Development and Validation

1Department of Chemistry, University of Mysore, Manasagangotri, Mysore 570 006, India
2PG Department of Chemistry, JSS College of Arts, Commerce & Science, Ooty Road, Karnataka, Mysore 570 025, India

Received 1 February 2014; Accepted 12 March 2014; Published 3 April 2014

Academic Editors: Z. Aydogmus, A. Bouklouze, G. Erny, A. Garcia Asuero, and W. X. Misiuk

Copyright © 2014 K. Basavaiah et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

An accurate, precise, sensitive, and rapid isocratic reversed phase high-performance liquid chromatographic (RP-HPLC) method for the analysis of olanzapine (OLP) in bulk drug and in tablets has been developed and validated. Analysis was performed on a 150 mm × 4.6 mm, 5 μm particle Intersil ODS 3V column with 10 mM disodium hydrogen phosphate buffer (pH 7.4)-acetonitrile (35 : 65) (v/v) as mobile phase at a flow rate of 1.0 mL min−1 with UV detection at 254 nm; the constant column temperature was 40°C. The runtime under these chromatographic conditions was less than 8 min. The calibration plot was linear over the concentration range of 2.5–20.0 μg mL−1 with limits of detection and quantification values of 50 and 200 ng mL−1, respectively. The precision and accuracy of the method were assessed by determination of validation data for precision (intraday RSD values of 0.11–0.28%, interday RSD values of 0.15–0.46%), accuracy (0.87–2.80% intraday, 0.33–1.80% interday), and specificity, in accordance with the ICH guidelines. The stability of standard solution and tablet extract was also studied over a period of 24 h. The method was applied for the determination of OLP in tablets with satisfactory results.