Application of Newly Developed and Validated Analytical Method for Interaction Study of Selected Cardiac Drug Under Clinical Trials for Combination Therapy

Blessy Rachel Thomas, Prasanth S.S, Panchami G.S, Reeba K.R · International Journal of Pharmaceutical Sciences Review and Research · 2023

This research work aims to develop a new, rapid, accurate, and precise FTIR method for the simultaneous estimation of Propranolol Hydrochloride and Amiodarone Hydrochloride.are used for the treatment of cardiovascular diseases and application of the developed FTIR method to determine interaction by closely observing their interactive peaks.Acc. to WHO, Cardiovascular diseases are a group of disorders of the heart and blood vessels.As per statistics, about 1.7 million deaths are reported yearly due to CVD.The developed method was validated according to ICH guidelines.Amiodarone Hydrochloride shows better solubility in methanol and the solubility of Propranolol Hydrochloride in methanol is increased by the addition of DMSO (Dimethyl sulfoxide).Sample preparation was not required since ATR method were used.For the drugs, FTIR Beer's-Lambert's law was obeyed in the concentration range of 0.5-5.0mg and 3.8-10.3mgrespectively.96.6% and 98.59% were the percentage recovery of the drugs respectively for FTIR.Correlation coefficient was found to be 0.996 for Propranolol and 0.999 for Amiodarone.FTIR.This method can be useful since no analytical method was developed for Propranolol and Amiodarone in combination.The applicability of the developed method was determined by carrying out interaction studies and concluded by a positive result of no physical interaction between both.

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