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

Abstract

The aim of present work was to develop a simple and sensitive, HPTLC for the quantitative estimation of Telmisartan in its single component tablet formulations (40 mg). Telmisartan was chromatographed on silica Gel 60 F254 TLC plate using Toluene:Methanol (7:3 v/v/v) as mobile phase. Telmisartan in methanol scanned by Camag TLC scanner 4 with UV visible detector over wavelength range 200 to 400 nm, showed R_f value of 0.46 at wavelength of 299 nm and selected for further studies. The method was validated in terms of linearity (1-3 ng/ml), precision (intra-day variation 1.61, inter-day variation 2.73), accuracy (81.55 to 87.51%) and specificity. The limit of detection and limit of quantification for Telmisartan were found to be 0.25 ng/spot and 0.7 ng/spot, respectively. It can be concluded from the results that the proposed method was accurate, precise and consistent the determination of Telmisartan 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 Telmisartan in bulk and pharmaceutical dosage forms.