Development and validation of HPTLC method for determination of betamethasone valerate in API and pharmaceutical dosage form

Author : Neha Sharad Sinnarkar and Manisha S. Phoujdar

The aim of present work was to develop a simple and sensitive, HPTLC for the quantitative estimation of Betamethasone Valerate in its single component cream formulations (20 g). Betamethasone Valerate was chromatographed on silica Gel 60 F254 TLC plate using Ethyl Acetate: n- Heptane: Toluene: Ethanol (5.1:2.4:1.2:0.3 v/v/v/v) as mobile phase. Betamethasone Valerate in methanol scanned by Camag TLC scanner 4 with UV visible detector over wavelength range 200 to 400 nm, showed Rf value of 0.34 at wavelength 246 nm and selected for further studies. The method was validated in terms of linearity (1-9 μg/ml), precision (intra-day variation 1.40, inter-day variation 1.71), accuracy (84 to 96%) and specificity. The limit of detection and limit of quantification for Betamethasone Valerate were found to be 0.97 μg/spot and 2.96 μg/spot, respectively. It can be concluded from the results that the proposed method was accurate, precise and consistent the determination of Betamethasone Valerate in dosage form. This method was validated as per ICH guideline Q2 (R1). Results suggest that this method can be used for routine estimation of Betamethasone Valerate in bulk and pharmaceutical dosage forms.

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