Abstract

DEVELOPMENT AND VALIDATION OF DULOXETINE AND PREGABALIN SIMULTANEOUSLY IN CAPSULE DOSAGE FORM BY UV-VIS SPECTROSCOPY AND HPLC

Khan Arshad* and Tabassum Hangad

ABSTRACT

An accurate, easy and quick UV and HPLC method was developedsimultaneously estimation of Duloxetine and Pregabalin in Capsuledosage form. The UV method carried out using Shimadzu 1780Double Beam UV-Vis Spectrophotometer with solvent methanol. ForHPLC method Neosphere C18 column, (150 x 4.6 mm, 3.5μm) with EZChrom Elite Compact Software used to carried out separation. Thecombination of Methanol and 10 mM ammonium acetate buffer in theratio of 60:40 v/v used as a mobile phase and detection was done at210nm. The retention time of Duloxetine and Pregabalin was found tobe 6.1833 min and 2.3167 min, respectively. Linearity range ofDuloxetine is 2-12μg/ml and for Pregabalin 5-30μg/ml. TheCorrelation coefficient of Duloxetine and Pregabalin was 0.9977 and0.9967 respectively. The %RSD show the accuracy of method. Themethod that was created followed the ICH Q2 (R1) guidelines in termof Linearity, Accuracy, Precision, Specificity, LOD, LOQ, Assay and Robustness. Based onthe experiment the developed method was appropriate for determining the levels ofduloxetine and Pregabalin in capsule dosage form.

Keywords: Duloxetine, Pregabalin, UV, HPLC, Method Development.