Analytical Method Development and Validation for the Simultaneous Estimation of Azelnidipine and Telmisartan

Abstract

A new, simple, rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validation of Azelnidipine and Telmisartan in its pure form as well as in combined marketed formulation. Chromatography was carried out on a Phenomenex Luna C18 (4.6mm×250mm) 5µm particle size column using a mixture of Methanol: Phosphate Buffer (pH-4.2) (37:63% v/v) as the mobile phase at a flow rate of 1.0ml/min, thedetection was carried out at 260 nm. The retention time of the Azelnidipine and Telmisartan was found to be was 2.133, 3.692±0.02 min respectively. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision, specificity and robustness. The method produce linear responses in the concentration range of 20-60mg/ml of Azelnidipine and 10-30mg/ml of Telmisartan.The inter-day and intra-day precisions were found to be within limits. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.