Trace Level Quantification of Poly-Dispersed Polyethyleneglycol Benzenesulfonate Esters in Drug Formulations by LC-MS Using Precursor-Ion Scanning

摘要

LC-MS methods applying precursor-ion mode in MS detection have been established for the quantification of PEG 400 monobesylate and PEG 6000 monobesylate at low ppm levels. The precursor-ion approach allows for collective detection of multiple precursors under the single analyte peak containing poly-dispersed species. The direct-injection LC-MS methods require no pretreatment for drug formulations with PEG and API matrices. Quantification levels for PEG 400 monobesylate and PEG 6000 monobesylate achieved 2 and 10 ppm, respectively.