Analytical Method Development & Validation for the Simultaneous Estimation of Tezacaftor and Ivacaftor by Rp HPLC in Solid Dosage Forms

AbstractThe pharmaceutical analysis plays a major role in assuring, identity, safety, efficacy, purity andquality of drug product the need for pharmaceutical analysis is driven largely by regulatoryrequirements. The main aim of the present study is to develop an accurate, precise, sensitive,selective, reproducible and rapid Analytical method development & validation for the Simultaneousestimation of Tezacaftor and Ivacaftor by RP HPLC in solid dosage forms. HPLC are reportedanalytical methods for compounds either individually or in combination with other dosage form.Method validation is the process to confirm that the analytical procedure employed for a specific testis suitable for its intended use. Analytical testing of a pharmaceutical product is necessary to ensureits purity, stability, safety and efficacy. Analytical method validation is an integral part of the qualitycontrol system. A simple, Accurate, precise method was developed for the simultaneous estimationof the Tezacaftor and Ivacaftorin Tablet dosage form. Retention time of Tezacaftor and Ivacaftorwere found to be 2.140min and 3.096min. %RSD of the Tezacaftor and Ivacaftor were and found tobe 0.1 and 0.4 respectively. %Recovery was obtained as 99.88% and 99.22% for Tezacaftor andIvacaftor respectively. Regression equation of Tezacaftor is y = 13967x + 3517, and y = 13443x +4757.2 of Ivacaftor. Retention times were decreased and that run time was decreased, so the methoddeveloped was simple and economical that can be adopted in regular Quality control test in Industries.