STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF IVACAFTOR AND TEZACAFTOR IN BULK AND PHARMACEUTICAL DOSAGE FORM
Dharmamoorthy G., G. Sarath Kumar*, Poornima B., P. Jayachandra Reddy and K. Chandan Kumar
A new simple, accurate, rapid and precise method was developed and validated for the simultaneous estimation of Ivacaftor and Tezacaftor in pharmaceutical dosage form. Chromatogram was run through Inertsil ODS C18 (250 x 4.6 mm, 5μ) Column. Mobile phase contains Phosphate buffer and Acetonitrile taken in the ratio 40:60 was pumped through column at a flow rate of 1 ml/min. The pH was adjusted to 3.2 with Orthophosphoric acid. Temperature was maintained at 25°C. Optimized wavelength selected was 259 nm. The retention times were found to be 3.285 and 4.635 minutes for Ivacaftor and Tezacaftor. % RSD of the Ivacaftor and Tezacaftor were found to be 0.1 and 0.7 respectively. % Recovery was obtained as 99.96% and 99.98% for Ivacaftor and Tezacaftor respectively. Signal to Noise ratio for LOD, LOQ values obtained from regression equations of Ivacaftor and Tezacaftor were found to be 3, 9.98 and 3.02, 10 respectively. 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: Ivacaftor, Tezacaftor, RP-HPLC.
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