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

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.