Development and Validation of a GC–MS Method for the Determination of Methyl and Ethyl Camphorsulfonates in Esomeprazole Magnesium

摘要

A rapid gas chromatography–mass spectrometry method for the identification and determination of two carcinogenic impurities viz. methyl camphorsulfonate (MCS) and ethyl camphorsulfonate (ECS) in esomeprazole magnesium (EOM) is developed for the first time. The factors affecting method development and the fragmentation patterns of MCS and ECS based on the mass spectral analysis are described. The limit of detection and limit of quantitation values for both compounds were established as 3 and 10 ppm, respectively with respect to 50 mg mL−1 of EOM. The method is linear within the range of 10–120 ppm and found to be precise, accurate, specific and robust.