VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF LUMACAFTOR AND IVACAFTOR IN PHARMACEUTICAL FORMULATIONS

Nagaraju Pappula* and B. Mounika

ABSTRACT

A simple, Accurate, precise method was developed for the simultaneous estimation of the Lumacaftor and Ivacaftor in Tablet dosage form. Chromatogram was run through AltimaC18 (150 x 4.6 mm, 5). Mobile phase containing Buffer:Acetonitrile taken in the ratio 55:45v/v was pumped through column at a flow rate of 0.9 ml/min. Buffer used in this method was KH2PO4. Temperature was maintained at 30°C. Optimized wavelength selected was 220 nm. Retention time of Lumacaftor and Ivacaftor were found to be 2.283 min and 2.759. %Recovery was obtained as 100.57% and 99.56% for Lumacaftor and Ivacaftor respectively. LOD, LOQ values obtained from regression equations of Lumacaftor and Ivacaftor were 1.06, 3.22 and 0.16, 0.48μg/ml respectively. Regression equation of Lumacaftor is y = 11244x + 12930, and y = 8284x + 7794.4of Ivacaftor. The developed method was simple and economical that can be adopted in regular Quality control test in Industries.

Keywords: Ivacaftor, Lumacaftor, RP-HPLC.