Validated LC-MS/MS method for ultra-trace determination of N-nitroso-desmethyl sumatriptan in sumatriptan succinate injection.
A rapid and highly sensitive LC-MS/MS method was developed and validated for the determination of the nitrosamine drug substance-related impurity N-nitroso-desmethyl sumatriptan (NNDS) in sumatriptan succinate injection. Separation was achieved on an Inertsil ODS-3 column using gradient elution with 0.1% formic acid in...