Development and Validation of Stability Indicating RP-HPLC Method for Azelnidipine for bulk drug.

Abstract

A Stability Indicating RP HPLC method was develop and validated for the determination of Azelnidipine using Phenomenex
C18 column (25 cm × 4.6 mm,5μm) with mobile phase consisting of Methanol: Water (75:25% v/v). The flow rate was kept
constant 1.0 mL/min and eluent was detected at 256 nm. In calibration curve experiments, Linearity was found to be in
concentration range 2-14 μg/ml (R2=0.9985) with regression equation y = 160134x + 3313.7
Azelnidipine was subject to stress condition including alkaline, acidic, oxidation, wet heat, thermal degradation and
photolysis. Azelnidipine is more sensitive towards acid degradation. Also there was no interference of excipient and
degradation product at retention time of Azelnidipine, indicating specificity of the method.