Abstract

Pravalika P.*, Devi T.1, Tejaswini P.2 and Nitish Singh

ABSTRACT

Purpose: The objective of the proposed method is to develop a validated RP-HPLC method for simultaneous estimation of Ivacaftor and Tezacaftor from a fixed dose combination drug product. Method: The chromatographic condition for detection was developed using column of phenomenex C18 with dimensions of 250 x 4.6 mm, 5?m with mobile phase containing buffer 0.1M potassium dihydrogen phospahte and acetonitrile taken in the ratio of 60:40 was pumped through column at a flow rate of 1 ml/min. The temperature was maintained at 30°C with wavelength of 270 nm and detected by using PDA detector. Results: The retention time of Ivacaftor and Tezacaftor was found to be 2.218 min and 2.813 min respectively. %RSD of the Ivacaftor and Tezacaftor was and found to be 0.8 and 0.9 respectively. Accuracy studies were done with % recovery obtained as 100.35% and 100.69% for Ivacaftor and Tezacaftor respectively. LOD, LOQ values for Ivacaftor and Tezacaftor were 0.38 ?g/mL, 1.14?g/mL and 0.09 ?g/mL, 0.28 ?g/mL respectively. Retention times was less when compared to the reported methods. Conclusion: The developed method was simple, precise, accurate, linear, rapid, economical and the method has the ability to separate both drugs in pharmaceutical dosage forms so it can be adopted in regular quality control test for the simultaneous estimation of Ivacaftor and Tezacaftor in tablet dosage form.