Abstract

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

Imdad Husen Mukeri, Amit Kumar Kushwaha, Netra Prasad Neupane, Ashutosh Kumar, Allen Sushant, Anant Nag and P. Malairajan*

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Abstract

Azelnidipine is a new dihydropyridine calcium channel antagonist with selectively for L-type calcium channel that has recently been approved in Japan for the treatment of patients with hypertension. The objective was to develop new UV- visible spectroscopy method for Azelnidipine which should be rapid, precise, accurate and sensitive and validate the develop method according to ICH guidelines by the use of API and tablet formulations of Azelnidipine by UV- visible spectroscopy. UVVisible Spectrophotometric determination was performed with Systronics PC- based double beam spectrophotometer 2202. A simple, Rapid, precise, accurate and sensitive UV- visible Spectroscopy method has been developed for the determination of Azelnidipine by using methanol as a medium. The spectrum of the standard solution was run from 200-400nm range for the determination of λmax and the λmax of Azelnidipine was found at 257nm. The absorbance of 2-14μg/ml of standard drug solution was measured at λmax 257nm. 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 2-14μg/ml and gave a mean correlation coefficient of 0.982. Accuracy was found to be 1.09%-0.83%. The precision expressed as relative standard deviation of Intraday and Interday which was 1.03%-1.70% and 1.26%- 1.67% with % RSD less than 2 and the limit of detection (LOD) and limit of quantitation (LOQ) for Azelnidipine was found to be 0.77 and 2.36 respectively. 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 UVVisible Spectroscopy, ? max at 257 nm, Absorbance Measure of Azelnidipine.