Abstract

VALIDATED HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHY METHOD FOR DETERMINATION OF DESVENLAFAXINE SUCCINATE IN TABLET

Hemant Tawale* and Madhukar Tajne

Abstract

A simple validated high-performance thin-layer chromatographic method has been proposed for the determination of Desvenlafaxine succinate in a tablet dosage form. The separation was achieved on silica gel 60 F254 coated aluminum sheet as stationary phase using ethyl acetate: n-hexane: triethyl amine (5.0: 4.5: 0.5 v/v/v) as mobile phase which gave compact spots with Rf value 0.60 ± 0.02. Quantitative densitometric evaluation was done in absorbance-reflectance mode at 226 nm. The response was found to be linear over concentration range of 100-500 ng/spot with correlation coefficients 0.991 and 0.999 and mean percentage recovery of the drug was observed to be 99.33 ± 0.561 and 99.28 ± 0.287 by peak area and peak height, respectively. The method was validated for linearity, accuracy, range, precision and robustness according to ICH Q2 (R1) guidelines. The method is simple, accurate, precise and was successfully applied to the assay of drug in tablet formulation.

Keywords: Desvenlafaxine succinate, Assay, HPTLC, Validation.