image
ISSN (Online) : 2277-4572

METHOD DEVELOPMENT AND VALIDATION OF DULOXETINE HYDROCHLORIDE IN BULK AND FORMULATION USING UV SPECTROPHOTOMETRIC METHOD

Abstract

Author(s): Kishore Methuku1*, Kiran Aarelly2, N.Raghunandan3, Manish Kumar Thimmaraju4

New, simple and cost effective UV-spectrophotometric method was developed for the estimation of Duloxetine hydrochloride in bulk formulations. Duloxetine hydrochloride was estimated at 290 nm in 20% Acetonitrie. Linearity range was found to be 10–50 μg ml–1 (regression equation: 0.017 + 0.016; r2 = 0.999). The apparent molar absorptivity was found to be 5.922×10-3 mol−1 cm−1 in 20% Acetonitrile. These methods were tested and validated for various parameters according to ICH guidelines and USP. The quantitation limits were found to be 0.2405 μg ml–1 and 0.7289 μg ml–1 in 20% Acetonitrile respectively. The results demonstrated that the procedure is accurate, precise and reproducible (relative standard deviation < 2%), while being simple, cheap and less time consuming and can be suitably applied for the estimation of Duloxetine hydrochloride in different dosage forms and dissolution studies.