RP-HPLC SEPARATION METHOD FOR INDIVIDUAL COMPONENTS OF POLYCAP IN PRESENCE OF THEIR DEGRADATION/INTERACTION PRODUCTS

Abstract

Polypill is a fixed dose combination, used as a single daily pill to achieve a large effect in preventing cardiovascular disease with minimal adverse effects. In the present study, gradient LC method was developed for simultaneous determination of the Polycap, that is, Atenolol, Hydrochlorothiazide, Aspirin, Ramipril, and Simvastatin, in presence of their major interaction/degradation products. The individual drug components and their major interaction/degradation products were well separated using reverse phase C₁₈ column and a mobile phase containing Acetonitrile:Phosphate buffer (pH 2.3). Other instrumental parameters were flow rate, 1 mL min⁻¹; detection wavelength, 230 nm; column oven temperature, 40°C; and injection volume, 5 µL. The combined drugs were subjected to stress conditions such as hydrolysis, oxidation, photolysis, and thermal decomposition. The method was validated for linearity, precision, accuracy, specificity, and robustness.

Keywords:

• atenolol
• HPLC
• hydrochlorothiazide
• keywords aspirin
• polycap
• ramipril
• simvastatin
• stability indicating

ACKNOWLEDGMENT

The authors wish to thank the management of the United States Pharmacopeia Laboratory-India and D. Eranna, NIPER Hyderabad, for wholeheartedly supporting this work

Notes

^a Regression equation y = mx + c where m is slope and c is intercept of regressed line.