Isocratic high-performance liquid chromatographic assay of olanzapine: method development and validation

摘要

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.