Development and Validation of an RP-HPLC Method for the Simultaneous Estimation of Azelnidipine and Telmisartan in Pharmaceutical Tablet Dosage Form

Abstract

A simple, precise, and accurate reverse-phase high-performance liquid chromatography (RP-HPLC) method to estimate Azelnidipine (AZL) and Telmisartan (TEL) in bulk and pharmaceutical dosage forms has been developed. A reverse-phase chromatography C18 column (250cm × 4.6mm × 5µm) with a mobile phase consisting of 0.2% triethylamine: Acetonitrile (20:80 V/V) having pH 3.0 adjusted using orthophosphoric acid. The flow rate was 1.0mL min and the effluents were monitored at 226nm. The retention time was found to be 6.0min for Azelnidipine and 3.8min for Telmisartan. The linearity of the drug was obtained in the range of Azelnidipine 1-5ml and Telmisartan 5-25ml. The results of the analysis have been validated according to the ICH guideline.