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DOVELOPMENT AND VALIDATION OF STABILITY INDICATING RP HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF IVACAFTOR AND TEZACAFTOR IN COMBINED DOSAGE FORM

  • Unique Paper ID: 153226
  • Volume: 8
  • Issue: 6
  • PageNo: 173-178
  • 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.
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Cite This Article

  • ISSN: 2349-6002
  • Volume: 8
  • Issue: 6
  • PageNo: 173-178

DOVELOPMENT AND VALIDATION OF STABILITY INDICATING RP HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF IVACAFTOR AND TEZACAFTOR IN COMBINED DOSAGE FORM

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