RP-HPLC Method for Determination of Azelnidipine and Telmisartan in Pharmaceutical Dosage Form

Abstract

An analytical method based on reverse phase-high performance liquid chromatography (RP-HPLC) has been developed and subsequently validated, which was found to be simple and rapid for the simultaneous quantification of azelnidipine and telmisartan in pharmaceutical dosage form. The separation was performed on an Intersil C18 column (250 × 4.6mm, i.d., 5µm) utilizing the mobile phase having composition 70 volumes of acetonitrile and 30 volumes of 5 millimolar phosphate buffer pH 4.6. The chromatographic analysis was carried on isocratic elution at a flow rate of 1mL/min. Detection was carried out with UV detector at 255nm, and linearity was found at concentration ranges of 10-50µg/ml for AZL and 20-100µg/ml for TEL. The recoveries obtained were 99.48‒100.22% for AZL, and 99.62 – 99.88% for TEL. No interference was found by the excipients in the formulation. The method was validated as per guidelines framed by International conference of harmonization for the parameter accuracy, precision, specificity, robustness, limits of detection and quantitation. The developed RP-HPLC method was applied in the analysis of commercial pharmaceutical products containing AZL and TEL and found to be efficient from recovery results.