Abstract

A NOVEL RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF CARDIOVASCULAR DRUGS IN A POLYCAP FORMULATION

Nazareth Celina*, Shivakumar B. and Reddy Prasad

ABSTRACT

Cardiovascular disease continues to occur in epidemic proportions globally and often requires multiple strategies for control and reversal, so as to reduce mortality and morbidity. A Polycap containing low dose Aspirin, a potent Statin (Simvastatin) and three BP lowering drugs at reduced standard dose (HCTZ –thiazide diuretic, Ramipril- ACE inhibitor and Atenolol- beta blocker) is available for use in primary and secondary prevention of cardiovascular events. Developing an analytical method for simultaneous estimation of components of FDC is challenging due to complexity caused by drugdrug and drug-excipient interference. A new, simple and rapid RPHPLC method has been developed for the simultaneous estimation of Aspirin, Simvastatin, Ramipril, Atenolol and Hydrochlorothiazide in a polycap formulation. A planar C18 (250 X 4.6 mm, 5 μ) chromatographic column was used for the separation. The mobile phase employed for the analysis was Methanol-Water (80:20, v/v) adjusted to pH 3.00 with dilute orthophosphoric acid, at a flow rate of 1.0 ml/min. The eluent was monitored at wavelength of 220 nm. The developed method was validated following ICH guidelines. The Beer Lambert’s range for each drug was established. The method was found to be accurate, specific, precise and robust. The developed method was applied in analysis of a Polycap formulation. The mean assay results for the drugs were within acceptance limits. The developed method is thus a valuable quality control tool for the routine analysis of the drugs by HPLC in bulk and in their polycap formulation without the need for their prior separation.

Keywords: Aspirin, Atenolol, Hydrochlorothiazide, Ramipril, Simvastatin, RP-HPLC, Polycap.