A SIMPLE RP-HPLC METHOD FOR SIMULTANEOUS ANALYSIS OF ASPIRIN, ATENOLOL, HYDROCHLOROTHIAZIDE, RAMIPRIL AND SIMVASTATIN IN PHARMACEUTICAL SOLID DOSAGE FORMS

Polycap (a capsule or pill) is a fixed-dose combination (FDC) containing three or more drugs in a single pill with the intention of reducing the number of tablets or capsules that need to be taken. Developing a single analytical method for the estimation of individual drugs in a combination is very challenging, due to the formation of drug-drug and drug-excipients. Here an attempt was made to develop a new, sensitive, single stability-indicating HPLC method for the simultaneous quantitative determination of aspirin, atenolol, hydrochlorothiazide, ramipril and simvastatin in a combinations form. A novel, simple and economic reverse phase high performance liquid chromatography (RP- HPLC) method has been developed for the estimation of Aspirin, Atenolol, Hydrochlorothiazide, Ramipril and Simvastatin in bulk and solid dosage forms with greater precision and accuracy. Separation was achieved on C18 column (150 x 4.6mm, 5μm) using gradient mobile phase Sol-A: buffer 4g of Sodium per chlorate i n 1 0 0 0 m L o f H P L C g r a d e w a t e r and Sol-B: acetonitrile gradient program (0-3min, sol-A: 98-90; 36min- sol-A: 90-50; 6-8min- sol-A: 50-50; 8-10min- sol-A: 50-25; 10-12min- sol-A: 25-98; 1220min- sol-A: 98-98) pumped in to the column at flow rate of 0.8ml/min and the detection of eluent from the column was carried out using variable wavelength detector at 220nm. The total run time was 20 min and the column was maintained at ambient temperature. The retention times of aspirin, atenolol, hydrochlorothiazide, ramipril and simvastatin were 2 . 6 min, 6 . 2 m i n , 7 . 6 m i n , 8 . 6 m i n and 13.0min, respectively. The method was validated as per ICH guidelines. Validation studies demonstrated that the proposed RP-HPLC method is simple, rapid, reliable and reproducible. The high recovery and low relative standard deviation confirm the suitability of the proposed method for the routine quality control analysis in bulk and solid dosage forms.