Analytical Method Development and Validation of Nicardipine by RP-HPLC

Research Article

Abstract

A novel approach was devised to estimate Nicardipine using RP-HPLC with Biorelevant Dissolution Media (FaSSIF). Optimal chromatographic conditions were established utilizing a Kromosil C18 column (4.5×150 mm, 5.0 µm), with a flow rate of 0.8 ml/min and a mobile phase comprising 65% methanol and 35% water. Detection was performed at 265nm using a WATERS HPLC Auto Sampler, Separation module 2695, equipped with a photodiode array detector 996 and Empower software version-2. Retention times were determined to be 2.428 mins, and the Nicardipine purity was assessed at 99.87%. System suitability parameters, including theoretical plates and tailing factor, were found to be 4146 and 1.23, respectively. Method validation was conducted following ICH guidelines (ICH, Q2 (R1)). The linearity study demonstrated Nicardipine's concentration range from 30µg to 150µg, with a correlation coefficient (r2) of 0.997, recovery rate of 100.4%, repeatability %RSD of 0.5, and intermediate precision %RSD of 1.0. Precision evaluation encompassed precision, robustness, and repeatability, with a LOD value of 2.97 and LOQ value of 9.92. Consequently, this RP-HPLC method is recommended for the routine analysis of Nicardipine in both active pharmaceutical ingredients (API) and pharmaceutical dosage forms