Development and validation of novel HPTLC method for the simultaneous estimation of Amlodipine Besylate and Telmisartan in tablet dosage form using ICH Q2 (R1) directions

Abstract

A new simple, specific, accurate, precise and robust normal phase high performance thin layer chromatography (HPTLC) method were developed and validated for simultaneous estimation of two antihypertensive drugs Amlodipine Besylate (AMB) and Telmisartan (TEL) in pharmaceutical dosage form. Chromatographic separation of the drugs was performed over aluminium plates precoated with silica gel 60F₂₅₄ as the stationary phase and solvent system comprised of chloroform: methanol: formic acid (8:2.5:0.5 v/v/v). Densitometric evaluation of the separated zones was performed at 251 nm. Analytical performance of the suggested HPTLC method was validated according to the ICH guidelines with respect to the linearity, accuracy, precision, detection and quantitation limits, robustness and specificity. The two drugs were satisfactory resolve with R_f values 0.57 ± 0.02 and 0.77 ± 0.02 for AMB and TEL, respectively. The linearity was studied in the concentration range 100–600 μg/ml for both AMB and TEL with a correlation coefficients (r²) >0.9997 and 0.9999, respectively. Statistical analysis showed that the developed method is repeatable and selective for the estimation of AMB and TEL in its pharmaceutical formulations.