A NOVEL STABILITY INDICATING UPLC METHOD FOR THE ESTIMATION OF TEZACAFTOR AND IVACAFTOR IN TABLET DOSAGE FORMAbstract
UPLC is a modern technique which refers to Ultra Performance Liquid Chromatography and enhances in three main areas: Speed, resolution, and sensitivity. In this present study, an accurate and precise UPLC method was developed and validated for the stability indicating assay method to estimate Tezacaftor and Ivacaftor simultaneously in both bulk and tablet dosage form. This method was developed using column HSS C18 (100 × 2.1mm 1.7m) with mobile phase 0.1% OPA Buffer: acetonitrile taken in the ratio 50:50. The flow rate was 0.3 ml/min with an 1 μl injection volume. The effluents were detected at a wavelength of 292 nm using the TUV detector. The method was validated concerning specificity, accuracy, linearity, precision, robustness. The correlation coefficient for Tezacaftor and Ivacaftor were found to be 0.999 and 0.999, respectively. Recovery of Tezacaftor and Ivacaftor in the formulation was found to be 99.97% and 99.65% respectively.
Shyamala * and D. Ashok
Department of Pharmaceutical Sciences, Osmania University, Hyderabad, Telangana, India.
19 February 2019
25 May 2019
14 June 2019
01 November 2019