APPLICATION OF STABILITY INDICATING HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC METHOD FOR QUANTITATION OF DESVENLAFAXINE IN PHARMACEUTICAL DOSAGE FORM

Abstract

This paper describes a sensitive, selective, precise, and stability-indicating high performance thin layer chromatographic method for the determination of desvenlafaxine both as a bulk drug and in formulation. The method uses aluminum plates precoated with silica gel 60F-254 as the stationary phase and solvent system ethyl acetate:toluene:methanol:ammonia 7:2:0.5:0.5, (v/v/v/v). This system gave compact spots for desvenlafaxine (0.48 ± 0.06). Desvenlafaxine was subjected to acid and alkali hydrolysis, oxidation, and photodegradation. The peaks of the degradation products were well resolved from that of the pure drug and had significantly different R f values. Densitometric analysis of desvenlafaxine was performed in the absorbance mode at 228 nm. The linear regression analysis data for the calibration plots showed a good linear relationship over concentration range of 100–1000 ng · spot−1. The mean values of the correlation coefficient, slope, and intercept were 0.9997 ± 0.04, 7.4521 ± 0.437, and 781.15 ± 0.51, respectively. The method was validated for precision, robustness, and recovery. The limit of detection and limit of quantitation were 10 and 100 ng · spot−1, respectively. Statistical analysis showed that the method is repeatable, selective, and can separate the drug from its degradation products and can be used to monitor stability.