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Abstract

A method for mass spectrometric analysis of a saliva sample possibly containing mycophenolic acid or its metabolites mycophenolic acid phenyl glucuronide (MPAG) or mycophenolic acid acyl-glucuronide (Acyl-MPAG), including the steps: (a) providing a saliva sample containing one or more drug or metabolites; (b) deproteinating the sample; (c) separating the one or more drug or metabolites from the saliva sample; and (d) analyzing the one or more drug or metabolites using a mass spectrometer. The sample containing one or more MPA or metabolites is obtained from in an oral fluid based biological samples i.e. whole saliva or saliva obtained by chemical or mechanical stimulation or from specific salivary glands. The size of the sample contains one or more MPA or metabolites is at least about 100 microL. A kit for use in mass spectrometric analysis of a sample may contain one or more MPA or metabolites from saliva samples, comprising: (a) reagents for deproteinating of the saliva sample, including internal standards; (b) reagents for separating the one or more MPA or metabolites from the saliva sample; (c) reagents for analyzing the one or MPA or metabolites using a mass spectrometer; (d) a solution of one or more MPA or metabolites in saliva samples; and (e) instructions for analyzing the one or more MPA or saliva using a mass spectrometer. The kit includes (a) mobile phase solutions; (b) a chromatography column; and (c) a quality control specimen.

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