STABILITY INDICATING DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF FORMOTEROL AND ACLIDINIUM RP-HPLC METHOD

Syed Reehana Saleen*, P. Sreenivasa Prasanna and K. Thejomoorthy

ABSTRACT

A simple, Accurate, precise method was developed for the simultaneous estimation of the Aclidinium and Formoterol in pharmaceutical dosage form. Chromatogram was run through Std BDS C8 150 x 4.6 mm, 5. Mobile phase containing Buffer 0.01N Kh2PO4: Acetonitrile taken in the ratio 65:35 was pumped through column at a flow rate of 1 ml/min. Buffer used in this method was 0.01N Kh2PO4 buffer. Temperature was maintained at 30°C. Optimized wavelength selected was 230 nm. Retention time of Formoterol and Aclidinium were found to be 2.146 min and 2.698. %RSD of the Formoterol and Aclidinium were and found to be 0.3% and 0.6% respectively. %Recovery was obtained as 100.76% and 99.67% for Formoterol and Aclidinium respectively. LOD, LOQ values obtained from regression equations of Formoterol and Aclidinium were 0.05, 0.56 and 0.15, 1.69 respectively. Regression equation of Aclidinium is y = 13617x + 3371.1, and y = 5306.5x + 149.57 of Formoterol. Retention times were decreased and run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.

Keywords: Aclidinium bromide, formoterol fumarate, validation, RP-HPLC, robustness.