Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF AZELNIDIPINE BY UV-VISIBLE SPECTROSCOPY

Girindra Lekhi*, Chandanam Sreedhar, T. Srinivasa Rao, Harsha K. Tripathy, Deepthi D. Kini

ABSTRACT

Azelnidipine is a dihydropyridine calcium channel antagonist that has recently received approval in Japan for the treatment of individuals with hypertension. It specifically inhibits L-type calcium channels. The objective was to develop a new, sensitive, rapid, accurate, and precise UV-visible spectroscopy approach for azelnidipine while validating the method in compliance with ICH guidelines using API and tablet formulations of the drug. Systronics PC-based double beam spectrophotometer 2202 was used to do UV Visible Spectrophotometric measurement. Using methanol as a medium, a simple, rapid, precise, accurate, and sensitive UV-visible Spectroscopy method has been developed to determine the presence of azelnidipine. The standard solution's spectrum was run in the 200-400 nm range to determine the maximum, and the maximum of azelnidipine was discovered at 255 nm. The absorbance of 2-12μg/ml of standard drug solution was measured at λmax 255nm. Validation parameters such as linearity, range, LOD and LOQ, accuracy, precision and robustness were evaluated as per ICH guidelines. Linearity for the UV-visible spectroscopy was noted in the concentration range of 2-12μg/ml and gave a mean correlation coefficient of 0.9761. Accuracy was found to be 0.12%-0.41%. The limits of detection (LOD) and limit of quantitation (LOQ) for azelnidipine were found to be 2.16 and 6.54, respectively. The precision was expressed as relative standard deviation of Intraday and Interday, which were 0.80%-1.34% and 0.67%-0.74%, respectively, with% RSD less than 2. The proposed UVvisible spectroscopy method and its validation according to the ICH guidelines shows that develop method is sensitive, precise, accurate and simple for the determination of Azelnidipine API and tablet formulation.

Keywords: Azelnidipine, UV-Visible Spectroscopy method, Method validation by UV-Visible Spectroscopy, ? max at 255 nm, Absorbance Measure of Azelnidipine.