A Study of Stability Indicating Development and Validation of a Method for Simultaneous Estimation of Brigatinib and Alectinib Using Reverse Phase Ultra Performance Liquid Chromatography in Active Pharmaceutical Ingredient Form

Abstract

Aims: New validated method for the simultaneous estimation of Brigatinib and Alectinib using UPLC and study of its degradation. Place and Duration of Study: Department of Chemistry, RVR & JC College of Engineering, Chowdavaram, Guntur, Andhra Pradesh, between March 2021 and April 2021. Methodology: Using Luna C18 100 x 2.6 mm, 1.6 µm column, acetonitrile, and 0.1 percent Tri ethyl amine (TEA) (80:20 v/v) as a mobile phase, the proposed method successfully achieved effective chromatographic separation with a flow rate of 1 mL/min and a wave length of 260 nm. The Braginib and Alectinib peaks were resolved within 5 minutes of elution time, with the Brigatinib peak eluting at 3.208 minutes and the Alectinib peak eluting at 1.757 minutes. Results: The proposed method displays excellent linearity in the concentration ranges of 1.0 µg/ml to 15 µg/ml for Brigatinib and 5.0 µg/ml to 75 µg/ml for Alectinib. The RSD of robustness levels has a maximum of just 2 percent. Conclusion: The accuracy, specificity, and sensitivity of the method were all found to be in line with ICH guidelines, when the procedure was developed and tested.