Development of RP-HPLC method for simultaneous estimation of Aspirin, Ramipril, Atenolol and Atorvastatin

Abstract

Polypill is envisaged to be a combination anti CVDs contained in the same dosage form unit. In that a polypill or Multicomponent cardiovascular pill (MCCP) is closest to ‘Fixed dose combinations (FDC)’ or its synonym ‘Fixed dose Combination-Finished pharmaceutical product’ (FDC-FPP). Developing a single analytical method for estimation of individual drug from a multidrug composition is a very challenging task. A simple, rapid, precise, and reliable reverse phase HPLC method was developed for the separation and estimation of four drugs Aspirin, Ramipril, Atenolol and Atorvastatin in cardiovascular polypill based synthetic mixture. The estimation was carried out using Inertsil ODS-3V (250 mm × 4.6 mm, 5 𝜇m) column; mobile phase consisting of acetonitrile, methanol and buffer (pH=2.5); flow rate of 0.8 mL/min and ultraviolet detection at 225 nm. All the drugs were properly eluted within run time of 10 min with retention times about 4.1 min for Aspirin; 5.9 min for Atorvastatin; 7.2 min for Atenolol; and 8.3 min for Ramipril 8.333 min, respectively. The method was validated as a final verification of method development with respect to precision, linearity, accuracy, ruggedness, and robustness. This validated method was successfully applied to the commercially available pharmaceutical dosage form, yielding very good and reproducible result.