ANALYTICAL QUALITY BY DESIGN BASED DEVELOPMENT AND VALIDATION OF A UPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF DEUTIVACAFTOR, TEZACAFTOR AND VANZACAFTOR

Abstract

For the simultaneous measurement of deutivacaftor, tezacaftor, and vanzacaftor in bulk and pharmaceutical dose forms, a UPLC technique based on analytical quality by design (aqbd) was created and verified using a mobile phase made up of buffer and organic solvent in a 60:40 (v/v) ratio at a flow rate of 0.3 ml/min, the chromatographic separation was accomplished on by HSS 100Å 100 x 2.1mm, 1.8µm column. 270 nm was the ideal wavelength for detection. retention times were shown as deutivacaftor at 0.942 minutes, vanzacaftor at 1.109 minutes, and tezacaftor at 1.304 minutes. SST %RSD values of 0.7%, 0.3%, and 0.5% for deutivacaftor, tezacaftor, and vanzacaftor, while method precision yielded %RSD values of 0.4, 0.1, and 0.4, indicating excellent reproducibility. the percentage recoveries were found to be 99.28% for deutivacaftor, 99.72% for tezacaftor, and 100.10% for vanzacaftor, confirming the method’s accuracy. the regression equations were determined as y = 10286x + 2613.8 for deutivacaftor, y = 10059x + 1491.2 for tezacaftor, and y = 15330x + 162.2 for vanzacaftor, demonstrating strong linearity.