Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF IVACAFTOR AND LUMACAFTOR IN BULK AND PHARMACEUTICAL DOSAGE FORM

Rupavath Suresh* and Dr. S. Shobha Rani

ABSTRACT

A simple, Accurate, precise method was developed for the simultaneous estimation of the Ivacaftor and Lumacaftor in bulk and Tablet dosage form. Chromatogram was run through Symmetry C18 150 x 4.6 mm, 5. Mobile phase containing Buffer 0.1% Formic acid:Methanol taken in the ratio 50:50 was pumped through column at a flow rate of 1.0 ml/min. Buffer used in this method was Ortho phosphoric acid. Temperature was maintained at 30°C. Optimized wavelength selected was 285 nm. Retention time of Lumacaftor and Ivacaftor were found to be 2.199 min and 2.825. %RSD of Lumacaftor and Ivacaftor were and found to be 1.2% and 1.1% respectively. %Recovery was obtained as 99.96% and 99.86% for Lumacaftor and Ivacaftor respectively. LOD, LOQ values obtained from regression equations of Lumacaftor and Ivacaftor were 0.53, 0.26 and 1.62, 0.78 respectively. Regression equation of Ivacaftor is y = 19840x + 7052.5, and y = 22138x + 8696.5 of Lumacaftor. Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.

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