Abstract

DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR DETERMINATION OF VENLAFAXINE HCL IN API AND PHARMACEUTICAL DOSAGE FORM.

Manisha Phoujdar*, Snehal Maske and Nilima Kenghe

Abstract

Objective: The aim of present work was to develop a simple and sensitive, HPTLC method for the quantitative estimation of Venlafaxine hydrochloride in its single component tablet formulations (37.5 mg). Method: Venlafaxine HCL was chromatographed on silica Gel 60 F254 TLC plate using Toluene: Methanol (4:6 v/v) as mobile phase. Venlafaxine HCL in methanol was scanned by Camag TLC scanner 4 with UV visible detector over wavelength range 200 to 400 nm. Results: Venlafaxine HCL showed Rf value 0.47 and scanned at 230 nm using Camag TLC Scanner. The method was validated in terms of linearity (2-7 μg/ml), Precision (intra-day variation 2.103, inter-day variation 3.08), accuracy for 80%, 100%, 120% (90.98%, 90.86%, and 85.30%) and specificity. The limit of detection and limit of quantification for Venlafaxine HCL were found to be 0.17μg/ml and 0.53μg/ml, respectively. Conclusion: It can be concluded from the results that the proposed method was accurate, precise and consistent in the determination of Venlafaxine HCL in tablet dosage form. This method was validated as per ICH guideline Q2 (R1). Results suggest that this method can be used for routine estimation of Venlafaxine HCL in bulk and pharmaceutical dosage forms.

Keywords: Venlafaxine HCL, Toluene, Methanol, HPTLC.