DEVELOPMENT AND VALIDATION OF AN ANALYTICAL METHOD FOR DULOXETINE HYDROCHLORIDE IN CAPSULE FORMULATIONS BY HPLC-UV

The objective of the current study was the development of a simple, precise and accurate isocratic reversed-phase High Performance Liquid Chromatography [Rp-HPLC] assay method and validated for determination of Duloxetine hydrochloride in capsule dosage forms. Isocratic separation was achieved on a C18 Inertsil ODS (5 mu, 250mmx 4.6mm) with flow rate of 1.0ml/min using UV detection at 230nm. The mobile phase composed of ammonium acetate buffer pH 5 adjusted with dilute acetic acid, methanol and Acetonitrile in the ratio of (50:20:30 v/v). The injection volume was 10.0 mu l and the detection was carried out at 230 nm by using photo-diode array detector. The method was validated for specificity, linearity, precision, accuracy, robustness and solution stability. The method was linear in the drug concentration range of 80-120 mu g/ml, with a correlation coefficient of 0.9999. The precision (% RSD) of six samples was 0.10 % for repeatability and the intermediate precision [RSD] among six-sample preparation was 0.142%. The accuracy (recovery) was between 99.58% and 100.97%. LOD and LOQ was found to be 0.0038 mu g/ml and 0.0126 mu g/ml. The proposed method was successfully used to determine the drug content of marketed formulation.