What question did this study set out to answer?

This research aims to develop and validate a method for detecting nitroso variants of leucovorin in drug products.

March 13, 2026Rapid Communications in Mass Spectrometry0 citations

Efficient and Simultaneous LC‐MS/MS Detection of N‐Nitroso and Di‐Nitroso Leucovorin in Leucovorin Drug Products: Method Development and Validation

JYJaya Yalamanchili HGHimavathi Ganja SSSuresh Salakolusu

Key Points

This research aims to develop and validate a method for detecting nitroso variants of leucovorin in drug products.
Developed a liquid chromatography-tandem mass spectrometry (LC-MS/MS) methodology.
Validated the method for accuracy and precision in measuring nitroso concentrations.
Tested the methodology on various leucovorin drug products.
Successfully quantified N-nitroso leucovorin and Di-nitroso leucovorin concentrations.
Demonstrated the method's effectiveness in regulatory compliance.
Indicated improved safety for patients using leucovorin products.

Abstract

This methodology will therefore offer a crucial solution to drug manufacturers to track and control N-nitroso leucovorin and Di-nitroso leucovorin concentrations, which will have a positive impact on regulatory compliance and patient safety.

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