A New RP-HPLC Method for the Determination of Tezacaftor and Ivacaftor in Bulk Form and Marketed Pharmaceutical Dosage Form

  • Unique Paper ID: 168069
  • Volume: 11
  • Issue: 4
  • PageNo: 1184-1191
  • Abstract:
  • The analytical method was developed by studying different parameters. First of all, maximum absorbance was found to be at 260 nm and the peak purity was excellent. Injection volume was selected to be 10µl which gave a good peak area. The column used for study was Symmetry C18 because it was giving good peak. Ambient temperature was found to be suitable for the nature of drug solution. The flow rate was fixed at 1.0ml/min because of good peak area and satisfactory retention time. Mobile phase is Methanol: TEA pH 4.2 (40:60) was fixed due to good symmetrical peak. So this mobile phase was used for the proposed study. Run time was selected to be 5 min because analyze gave peak around 2.781, 4.048 ±0.02 min respectively and also to reduce the total run time. The percent recovery was found to be 98.0-102 was linear and precise over the same range. Both system and method precision was found to be accurate and well within range. The analytical method was found linearity over the range 37.5-187.5µg/ml of Ivacaftor and 25-125 µg/ml of Tezacaftor of the target concentration. The analytical passed both robustness and ruggedness tests. On both cases, relative standard deviation was well satisfactory.

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