DEVELOPMENT AND VALIDATION OF NOVEL ANALYTICAL METHOD FOR IVABRADINE IN BULK AND DOSAGE FORM BY UV VISIBLE SPECTROPHOTOMETRY
Bindu R.*, Alakananda M. R., Adhila Samad, Geethika Ashok, Krishnapriya E., Vaishnavi S., Ayda Cherian, Shyni Bernard
ABSTRACT
This research centers on the establishment and validation of a novel analytical approach for the quantifying Ivabradine in bulk and dosage forms employing UV-visible spectroscopy with Ferric phenanthroline as a complexing reagent. Ivabradine, an antianginal drug, is crucial for managing chronic stable angina and heart failure by blocking the HCN channel in the sinoatrial node (SAN) of the heart. The study outlines the method's optimization, including the determination of optimal reagent volumes and heating times, to enhance the sensitivity and accuracy of the analysis. A calibration curve was established, demonstrating a linear relationship between absorbance and concentration across the 2–8 μg/ml range, with a correlation coefficient of 0.9996. The molar absorptivity was calculated at 0.10626, indicating a reliable method for quantifying Ivabradine. Validation parameters such as accuracy, precision, and robustness were assessed, yielding recovery rates between 97-102% and relative standard deviations below 2%. The method was environmentally friendly, aligning with green analytical chemistry principles. This study provides a cost-effective and efficient approach to routine quality control of Ivabradine in pharmaceutical formulations.
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