METHOD DEVELOPMENT AND VALIDATION AND STABILITY STUDIES FOR THE SIMULTANIOUS ESTIMATION OF TEZACAFTOR AND IVACAFTOR IN TABLET DOSAGE FORM BY RP-HPLC METHOD

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.