Abstract
METHOD DEVELOPMENT AND VALIDATION AND STABILITY STUDIES FOR THE SIMULTANIOUS ESTIMATION OF TEZACAFTO | Open Access
Volume 2024 - 1 | Article ID 216 | http://dx.doi.org/10.62057/ESJ.2024.V1.I2
METHOD DEVELOPMENT AND VALIDATION AND STABILITY STUDIES FOR THE SIMULTANIOUS ESTIMATION OF TEZACAFTOR AND IVACAFTOR IN TABLET DOSAGE FORM BY RP-HPLC METHOD
Academic Editor : Dr. Ahmed G. Hegazi
Received 2024-01-08 |
Revised 2024-01-08 |
Accepted 2024-01-10 |
Published 2024-01-20 |
A simple, Accurate, precise method was developed for the simultaneous estimation of the
Tezacaftor and Ivacaftorin Tablet dosage form. Chromatogram was run through Std BDS 150
x 4.6 mm, 5. Mobile phase containing NaH2PO4Buffer: Acetonitrile taken in the ratio 50:50at
1ml/min flow rate. Optimized wavelength selected was 292nmRetention time of Tezacaftor
and Ivacaftor were found to be 2.088 min and2.482 min. %RSD of the Tezacaftor and Ivacaftor
were and found to be 0.3 and 0.4singly. LOD, LOQ values obtained from regression equations
of Tezacaftor and Ivacaftor were 0.16, 0.49 and 0.33, 1.00singly. Regression equation of
Tezacaftor is y = 14384x + 2974, and y = 26897x + 4791of Ivacaftor. 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.