DEVELOPMENT AND VALIDATION OF UV-VISIBLE SPECTROSCOPIC METHOD FOR ESTIMATION OF NICORANDIL IN BULK AND ITS PHARMACEUTICAL FORMULATAION

Dr. R. Xavierarulappa*, M. Jerubin Welsingh, Christal Lini, V. Abisha and C. B. Anisha

ABSTRACT

Objective: The aim of the present work was to develop and validate a simple UV spectroscopic method for the determination of nicorandil, which is a nicotinamide nitric oxide ester derivative with vasodilatory and cardioprotective effect and it also act as a nitric oxide donor, increasing intercellular CAMP protection leading to venodilation and pain suppression. Method: The UV spectrophotometric analysis was performed using Systronics UV-spectrophotometer 2704 X visible double beam by using solvent system ammonium acetate buffer and acetonitrile in the ratio 8:2. Detection was performed at a wavelength of 260nm. Method validation was carried out according to ICH Q2R1 guidelines by taking the parameters linearity, accuracy, precision, ruggedness and robustness, LOD and LOQ. Results: The UV spectrophotometric was found linear in the range 10-50μg/ml. The method was rugged and robust with % relative standard deviation less than 2. The extraction recoveries was found to be higher than 99%in all experimental conditions. Conclusion: Based upon the performance characteristics, the proposed method was found accurate, precise and rapid and suitable for the determination of nicorandil for routine analysis.

Keywords: Nicorandil, UV- Spectrophotometry, Method development, Validation.