Development and validation of HPLC method for simultaneous determination of amlodipine besylate, telmisartan and hydrochlorothiazide in combined tablets

Abstract

Introduction: A combination of three active ingredients amlodipine besylate, telmisartan, and hydrochlorothiazide has been used and proven effective in the treatment of hypertension in patients with moderate to severe hypertension, while it contributes to a reduction in product costs and increases patient compliance. However, there are no monographs in pharmacopoeias for the simultaneous quantification of these three active ingredients. Therefore, in order to contribute to the establishment of an in-house specification for domestic generic drugs, shorten the time of quantifying each ingredient separately, the study was carried out with the aim of developing and validating procedure for the simultaneous quantification of amlodipine besylate, telmisartan, and hydrochlorothiazide by high performance liquid chromatography. Methods: In this study, we conducted an investigation into different chromatographic conditions, developed an analytical procedure for the simultaneous quantification of amlodipine besylate, telmisartan, and hydrochlorothiazide in tablets preparation. The procedure was validated in compliance with ICH guidelines. Results: Suitable chromatographic conditions for simultaneous quantification of amlodipine besylate, telmisartan, and hydrochlorothiazide are: Xterra C18 column (250 x 4.6 mm, 5 μm), detection wavelength 230 nm, gradient program of mobile phase: acetonitrile and phosphate buffer pH 3.0, flow rate 1.0 ml/min, sample injection volume 10 μl, column temperature 30°C. The procedure was validated for systematic suitability, accuracy, specificity, linearity, precision, working range, and robustness. Conclusion: A procedure for the simultaneous quantification of amlodipine besylate, telmisartan, and hydrochlorothiazide in tablets by high performance liquid chromatography has been successfully developed and validated.