A Stability Indicating RP-HPLC Method Validation for Simultaneous Estimation of Azelnidipine and Telmisartan in a Fixed-dose Combination

Abstract

The present investigation deals with the reverse phase high performance liquid chromatography (RP-HPLC) method validation for simultaneous estimating Azelnidipine and Telmisartan in a fixed-dose combination (FDC). The method was developed using RP-HPLC, Inertsil C-18 Column with 150×4.6 mm×5 µm at column oven temperature 40°C, flow rate 1.5 mL/min, volume 10 µL and run time 12.0 minutes at 254 nm using Acetonitrile and buffer as mobile phase in gradient mode. The developed protocol was most accurate, repeatable, and detectable towards Azelnidipine and Telmisartan in combination without any unwanted interference. When evaluated on various parameters like system suitability, precision, accuracy, linearity, robustness, force degradation study, the method is efficient in separating the API from its degradants and can be utilized for analyzing the samples of Azelnidipine and Telmisartan.