Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF IVABRADINE HYDROCHLORIDE IN BULK AND IN TABLET FORMULATION.

Bhosale Swati D.*, Vanjari Suvarna S. and Jagtap Nikhil S.

ABSTRACT

To develop simple, accurate, precise and cost effective UV-VIS Spectrophotometric method for the estimation of Ivabradine in bulk and pharmaceutical dosage form. Ivabradine is used to treat angina Pectoris. The solvent used was Methanol and the λmax or the absorption maxima of the drug was found to be 287nm. Ivabradine was subjected to stress degradation under different conditions recommended by ICH. The sample so generated was used for degradation studies using the developed method. A linear response was observed in the range of 5-25μg/ml with a regression coefficient of 0.998. The method was then validated for different parameters as per the ICH (International Conference on Harmonization) guidelines. The stress degradation studies showed that Ivabradine undergoes degradation in acidic, oxidative and alkaline conditions whereas it is relatively stable to neutral .This method can be used for the determination of Ivabradine in quality control of formulation without interference of the excipients.

Keywords: Ivabradine Hydrochloride, Degradation, Stability- Indicating UV-Visble Spectrophotometry, Validation.