Ramipril

Ramipril is a prodrug of the active metabolite ramiprilat, it inhibits angiotensin-converting enzyme and consequent raise in blood pressure. Its pharmacologic effect aids the treatment of hypertension, congestive heart failure and reduces mortality in post myocardial infarction patients. As for other drugs, Ramipril might degrade upon storage and compromise the quality, efficacy and safety of the product. In order to avoid deterioration, it is important to characterize the degradation products and source of stress (temperature, water content, oxidizers, etc). This review aims to summarize the data concerning the subject and serve as a guide for further studies.

A HPLC method for simultaneous estimation of Ramipril and Hydrochlorothiazide in tablets was developed and validated. The developed method involves Purosphere® Star Rp18e, 5μm, 150×4.6mm column with mobile phase composition of acetonitrile and sodium perchlorate (pH 2.5) buffer in the ratio of 3:2, at a flow rate of 1.0 ml/min and UV detection at 316nm for first five minutes for Hydrochlorothiazide and 210nm for Ramipril. The method was validated as per ICH guidelines, Linearity was observed over concentration range of 17.5 to 32.5 µg/ml for Ramipril and 87.5 to 162.5 µg/ml for Hydrochlorothiazide. The Accuracy of the proposed method was determined by recovery studies and found to be 97.95-102.3% and 97.98-102.66% for Ramipril and Hydrochlorothiazide respectively. The proposed method was extended for estimation of Ramipril and Hydrochlorothiazide in marketed tablet formulation (Ramace-HTM) and it was found to be well within the acceptance limit. The developed and validated HPLC method for simultaneous estimation of Ramipril and Hydrochlorothiazide was found to be linear, accurate, precise, robust and rugged. Hence it can be used for routine analysis of Ramipril and Hydrochlorothiazide in tablets.