Newer Rp-Hplc Method Development And Validation For The Simultaneous Estimation Of Telmisartan And Amlodipine In Dosage Form
Keywords:
Telmisartan and Amlodipine, RP-HPLC, Simultaneous Estimation, Pharmaceutical Dosage Forms, Waters HPLCAbstract
A novel and efficient Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method has been developed and validated for the simultaneous estimation of Telmisartan and Amlodipine in pharmaceutical dosage forms. The primary objective of this study was to establish a reliable and reproducible RP-HPLC method with optimized chromatographic conditions, ensuring the accurate determination of both drugs in combination. The method employs a Waters HPLC system equipped with an auto-sampler and a PDA Detector 996 model. The chromatographic separation was achieved using a Phenomenex Luna C18 column (4.6×250 mm, 5 µm particle size) under the following optimized conditions: the mobile phase consisted of a mixture of Acetonitrile and phosphate buffer (45:55 v/v), with a flow rate of 1 mL/min. The pH of the buffer was adjusted to 4.6 using diluted orthophosphoric acid, ensuring stability and efficient separation. The detection was carried out at a wavelength of 245 nm, and the injection volume was 10 µL. The column temperature was maintained at 35ºC to optimize the resolution and retention times of both drugs. The total run time for each analysis was 7 minutes. The method was validated in accordance with ICH guidelines for specificity, linearity, accuracy, precision, LOD, and LOQ. The results demonstrated good separation with no interference from excipients, and both drugs were found to elute with sharp peaks, ensuring accurate quantification. The method showed excellent linearity with correlation coefficients (r²) greater than 0.999 for both Telmisartan and Amlodipine in the tested concentration range. The method was successfully applied to the estimation of both drugs in commercial tablet formulations.