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.
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