NEWER RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUSESTIMATION OF TELMISARTAN AND AMLODIPINE IN DOSAGE FORM

27^th International Congress on Pharmaceutical Biotechnology Research

June 23-24, 2025 Webinar

Jyothsna K, Upendra U, Rajkiran K

Department of Pharmaceutical , Sri Sivani College of Pharmacy, India

Scientific Tracks Abstracts: Pharm Regul Aff

Abstract :

A novel reverse-phase high-performance liquid chromatography (RP-HPLC) method for simultaneously estimatingTelmisartan and Amlodipine in combined pharmaceutical dosage forms is the focus of this study. Amlodipine, a calciumchannel blocker, and telmisartan, an angiotensin II receptor antagonist, are frequently combined in treatment forhypertension. The need for a reliable, accurate, and rapid analytical method to simultaneously quantify both drugs in asingle formulation has become essential due to the growing use of combination therapies. A newly optimized RP-HPLC method was developed using a C18 column with a mobile phase consisting of acetonitrileand phosphate buffer (pH adjusted to 3.5 with orthophosphoric acid) in a suitable ratio.Using a UV detector, thedetection was carried out at a wavelength of 238 nm at a flow rate of 1.0 mL/min. The retention times of Telmisartanand Amlodipine were found to be well resolved with good peak symmetry and resolution.The developed method was validated in accordance with ICH Q2(R1) guidelines for various parameters including linearity,accuracy, precision, specificity, robustness, limit of detection (LOD), and limit of quantification (LOQ). The methodexhibited excellent linearity over the concentration ranges of 10–60 μg/mL for Telmisartan and 2.5–15 μg/mL forAmlodipine. The recovery studies demonstrated an acceptable percentage of recovery, demonstrating the method'saccuracy. The proposed RP-HPLC method is simple, precise, and time-efficient and can be effectively employed for the routine quality control analysis of Telmisartan and Amlodipine in combined dosage forms, validation, pharmaceutical dosage form, ICH guidelines, analytical method, hypertension

Biography :

K.Jyothsna has her own experience in valuation and passion for ML and data. The research team built this model after many years of e xperience in research, evaluation, work in both hospitals and scientific laboratories. This approach meets all the requirements forprecise, specific, sensitive diagnostics.