DOVELOPMENT AND VALIDATION OF STABILITY INDICATING RP HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF IVACAFTOR AND TEZACAFTOR IN COMBINED DOSAGE FORM
Author(s):
V MOUNIKA, A. Suneetha, M. Ramya
Keywords:
Ivacaftor, Tezacaftor, RP-HPLC
Abstract
A simple, accurate, precise method was developed for the simultaneous estimation of the ivacaftor and tezacaftor in bulk and tablet dosage form. Chromatogram was run through discovery 250 x 4.6 mm, 5μ. Mobile phase containing buffer 0.01N potassium dihydrogen ortho phosphate: acetonotrile taken in the ratio 50:50 was pumped through column at a flow rate of 1 ml/min. Buffer used in this method was 0.01N potassium dihydrogen buffer. Temperature was maintained at 30°C. Optimized wavelength selected was 290 nm. Retention time of ivacaftor and tezacaftor were found to be 2.373 min and 2.967. %RSD of method precision of ivacaftor and tezacaftor were found to be 0.8 and 0.8, respectively. %Recovery was obtained as 100.69% and 100.81% for ivacaftor and tezacaftor respectively. LOD & LOQ values obtained from regression equations of ivacaftor and tezacaftor were found to be 0.22, 0.66 and 0.15, 0.46, respectively. Regression equation of ivacaftor is y = 31543x + 76309, and tezacaftor is y = 24409x + 4287. Retention times were decreased and that run time was decreased, so the developed method was simple and economical that can be adopted in regular quality control test in Industries.
Article Details
Unique Paper ID: 153226

Publication Volume & Issue: Volume 8, Issue 6

Page(s): 173 - 178
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