Quantification of Telmisartan and Azelnidipine Combination in using Liquid Chromatography: Stability Studies

Abstract

A stability-indicating RP-HPLC method for the development of Telmisartan (TTN) and Azelnidipine (ADN) is analyzed in tablet dosage form. The quantification of TTN and ADN combination is done by Supel cosil C18 column (250 mm, 4.6 mm, & 5 µm). Isocratic mobile phase had mobile phase consists of 0.10M Na2SO4(pH 3.6) and acetonitrile (pH 3.6) as 55:45v/v. For this analysis flow rate is measured as 1.00 ml/min. Wavelength is identified as 258nm to examine TTN and ADN. Stability for both these drugs under distinctive environments were performed. Injected volume is 10μL. Run time is 8min. Retention time is 2.8 and 3.7 respectively. The responses were linear in the concentrate range as 37.4-110.3 for TTN and 2.24-10.51 µg/mL for ADN respectively. Percent comparative standard deviance to precision is 0.193% for TTN, 0.195% for ADN. Percent assay to accuracy for both these drugs are 98.76% and 99.04% respectively. LOD values for TTN and ADN were 0.020μg/ml and 0.065μg/ml and LOQ values for TTN and ADN were 0.009μg/ml and 0.031μg/ml. Robustness studies revealed that this method is robust by percent comparative standard deviance. This stability-indicating RP-HPLC procedure to both TTN, ADN analysis is more simple, highly sensitive, more precise, highly specific and robust, making it appropriate to the assessment of TTN and ADN in formulation.