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

Gunturu Raviteja, Kantipudi Rambabu
2022 Journal of Pharmaceutical Research International  
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
more » ... ation 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.
doi:10.9734/jpri/2022/v34i9a35498 fatcat:fptginh26fgk5o2vxqbubxucyu