RP-HPLC Method Development And Validation For Simultaneous Estimation Of Amlodipine Besylate, Telmisartan And Bisoprolol Fumarate In Synthetic Mixture
Year: 2026
Type: article
Abstract: The goal of the current study was to create and validate a straightforward, accurate, repeatable, and precise reverse-phase high-performance liquid chromatographic (RP-HPLC) method for the simultaneous estimation of Bisoprolol fumarate, Telmisartan, and Amlodipine besylate in a combination pharmaceutical dosage form.A C18 column with a mobile phase of buffer and acetonitrile (56:44, v/v) at a flow rate of 1.0 mL/min was used to accomplish chromatographic separation, and detection was carried out at 225 nm.The chromatographic conditions were optimized through systematic trials to obtain satisfactory resolution and peak characteristics.The developed method was validated according to ICH Q2 guidelines for specificity, linearity, precision, accuracy, limit of detection, limit of quantification, and robustness.The retention times of Bisoprolol fumarate, Amlodipine besylate, and Telmisartan were approximately 2.34, 4.18, and 15.03 min, respectively.The method exhibited excellent linearity with correlation coefficients greater than 0.998.Precision studies showed %RSD values below 2%, while recovery values ranged from 98% to 102%, confirming satisfactory accuracy.No interference from formulation excipients was observed, demonstrating good specificity.The method also remained robust under minor variations in chromatographic conditions.The validated RP-HPLC method is suitable for routine quality control analysis of these drugs in combined pharmaceutical formulations.
Institution: Swarrnim Startup and Innovation University
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: bronze
OpenAlex ID: W7203792455