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Simultaneous analysis of drug substances according to USP assay and impurity methods Be the first to rate this application


This application note describes a comprehensive analysis of a drug substance. Specifically, the analysis requires two different eluent compositions for the determination of drug content and impurities of esomeprazole magnesium according to the United States Pharmacopeia (USP) monograph. With conventional (U)HPLC systems, this would either require two different systems or sequential analyses.
Market: Pharma
Keywords: Esomeprazole, HPLC, Omeprazole, USP, Impurities, Assay, productivity, Vanquish Duo for Dual LC, parallel analysis, throughput, pharmacopeial monograph
Matrix: Acetonitrile, phosphate buffer
Author: Sylvia Grosse*, Alessandra Mantani*, Mauro De Pra*, Bhushan Pandit**, Frank Steiner*
Affiliation: *Thermo Fisher Scientific, Germering, Germany; **Thermo Fisher Scientific, Mumbai, India
Uploaded on 9/2/2022.

For Research Use Only. Not for use in diagnostic procedures.