New Stability Indicating RP-UPLC Method for Simultaneous Estimation of Telmisartan and Azelnidipine in Bulk and Combined Bilayer Film-Coated Tablet Dosage Form

Abstract

An efficient, perceptive, sensitive, accurate and economical RP-UPLC method with tunable UV detector has been developed for the simultaneous estimation of telmisartan and azelnidipine in bulk powders and their combined film-coated bilayer tablet dosage form. The proposed method employs Agilent Zorbax Stable Bond (SB) packing C8 (100 mm × 2.1 mm, 2 μm) column, a mobile phase consisting of 0.01 N potassium dihydrogen orthophosphate (pH 4.8) and acetonitrile in 70:30 v/v ratio pumped at a flow rate of 0.3 mL/min, and the UV detector tuned to 257 nm wavelength, which reliably separates all analytes with good resolution. Telmisartan and azelnidipine were eluted from the column at 0.675 and 1.601 min, respectively. Linearity of the telmisartan and azelnidipine determination was observed in the range of 20 – 120 μg/mL and 2 – 12 μg/mL, respectively. Computed values of the validation parameters confidently show that the method is specific, accurate and precise with high sensitivity. Exploration of the analytes under various forced degradation conditions with the help of the proposed method confirms stability-indicating character of the method. The developed method has high efficiency in separating telmisartan and azelnidipine and ensures their stability-indicating assay with good sensitivity and specificity, thus being adapted to the pharmaceutical industry applications.