Liquid chromatography–tandem mass spectrometry method for the determination of cefuroxime axetil diastereoisomers: application to stability-indicating method

Abstract

A liquid chromatography–tandem mass spectrometry (LC–MS/MS) method has been executed and validated to quantify cefuroxime axetil in the presence of its degradation products. Cefuroxime axetil and its degradation products were resolved with time programmed gradient elution on Eclipse XDB-C18 column (100 × 4.6 mm, 3.5 µm, Agilent, USA) kept at 40 °C. Under negative ion electrospray ionization, the analyte was quantified and monitored on a triple quadrupole mass spectrometer using multiple reaction monitoring scanning mode. Good results concerning the different validation parameters of the cefuroxime axetil were collected. The linearity was established in the range of 1.0–1000 ng mL−1 and showed an excellent correlation coefficient value (r ≥ 0.999). A comprehensive stress testing of cefuroxime axetil has been implemented according to the International Conference on Harmonization guidelines Q1A (R2).