Development and validation of an eco-friendly LC–MS/MS method for pharmacokinetic profiling of cyclophosphamide and capecitabine using quality by design principles

Key Points

• This research aims to develop and validate an eco-friendly LC–MS/MS method for profiling the pharmacokinetics of cyclophosphamide and capecitabine.
• Developed a quality by design (QbD) approach to optimize the LC–MS/MS method.
• Validated the method for pharmacokinetic analysis of cyclophosphamide and capecitabine.
• Assessed the eco-friendliness of the method during development.
• The developed method showed high sensitivity and specificity for both medications.
• Validation metrics met regulatory standards, demonstrating reliability for pharmacokinetic studies.
• The eco-friendly approach reduced the environmental impact compared to traditional methods.