Forced degradation studies and structural characterization of related substances of bisoprolol fumarate in finished drug product using LC-UV-MS/MS

Methods for determination of bisoprolol and related substances mostly use UV detection a phosphate buffer are not suitable MS detection. In this study, LC?UV?MS/MS separation characterization was developed, validated applied studying the degradation products when exposed to hydrolytic stress, heat light. The method uses C18 column, formic acid in water acetonitrile as mobile phases, gradient elution Forced revealed that hydrolysis produces most intensive transformation its impurity A, along with impurities L D. Alkaline produced L, Q, G K; oxidative thermal K, while photodegradation all characterized by their mass spectral data. developed using two systems demonstrated efficient since spectra allowed identification quantification possible absorbance measurements at 270 nm. obtained results will fill lack data on fragmentation patterns could be used researchers practitioners research quality control laboratories.