Alcaftadine: Selective Separation and Characterization of Degradation Products by LC–QTOF-MS/MS

Abstract

A rapid, precise and accurate gradient UPLC method was developed for the selective separation of degradation products of alcaftadine. Forced degradation studies of the drug were carried out by examining factors suggested by ICH guidelines. The degradation products were formed in acidic, alkaline and peroxide conditions; however, the drug was stable in neutral, thermal and photolytic degradation conditions. The chromatographic separation of the degradation products and the drug was carried out using an ACQUITY CSH C18 (100 × 2.1 mm, 1.7 µm) column and a mixture of ammonium acetate buffer (10 mM, pH 5.0) and methanol was used as mobile phase. The UPLC method was extended to UPLC–quadrupole time-of-flight tandem mass spectrometry for the characterization of the degradation products. Detection was achieved by PDA at 284 nm. The proposed method can be used in quality control for the determination of impurities of alcaftadine and for its stability studies. The developed method was validated in terms of specificity, linearity, accuracy, precision and robustness according to the ICH guidelines.