Development and validation of a HILIC-MS/MS method for the quantitation of fructose in human urine in support of clinical programs.

In a previous publication [1], a 20-minute UPLC®-MS/MS method, employing a surrogate analyte approach, was developed and validated to measure fructose and sorbitol, as mechanistic biomarkers, in human plasma to support first-in-human (FIH) studies. Different from plasma which maintains its homeostasis, urine has no such homeostasis mechanisms [2], therefore it is expected to be able to accommodate more changes. Here we describe the development and validation of a LC-MS/MS method for the quantiation of fructose in human urine to support clinical trials.

Development and validation of a quantitative ultra performance LC hydrophilic interaction liquid chromatography MS/MS method to measure fructose and sorbitol in human plasma.

Aim: Fructose and sorbitol are utilized as biomarkers for nonalcoholic steatohepatitis. Measurement of fructose and sorbitol levels helps understanding disease progression, drug response and underlying mechanism.

Materials & Methods: Stable isotope-labeled fructose and sorbitol were used as surrogate standards and internal standards.