Impurity profiling of Azelnidipine and Telmisartan in Fixed Dose Combination using Gradient RP-HPLC Method

Abstract

The objective is to develop and validate, stability indicating RP-HPLC method used for the determination and quantification of possible degradants & impurities present in Azelnidipine and Telmisartan in 8mg/40mg fixed-dose combination (FDC) tablets. The method was developed using RP-HPLC, Inertsil C-18 Column with 150×4.6 mm×5 µm, flow rate 1.5 mL/min, Injection volume10 µL, column oven temperature 40°C and run time 40.0 minutes at 254 nm using Acetonitrile and buffer as mobile phase in gradient mode. The developed method was accurate, repeatable, and detectable towards determination of Impurties present in Azelnidipine and Telmisartan combination without any unwanted interference. When evaluated on various parameters like system suitability, precision, accuracy, linearity, force degradation study, solution stability, it can be concluded that the method is efficient in separating drugs from their Impurties and can be utilized for analyzing the samples of Azelnidipine and Telmisartan.