Standard Reference Materials: SRM 900, Antiepilepsy Drug Level Assay Standard

摘要

Recognition of the efficacy of monitoring the concentrations of therapeutic drugs in the blood of patients has revealed many needs for standardization of the laboratory tests used for such monitoring. The National Bureau of Standards was asked to provide a Standard Reference Material (SRM) consisting of three serum samples, each to contain four antiepilepsy drugs at different concentrations. The four drugs are phenobarbital, phenytoin, primidone, and ethosuximide. The SRM would fill a basic role for achievement of accurate analysis to help ensure the reliability of analysis for these drugs. The needs that had to be fulfilled to produce the SRM included: (1) analytical criteria for purity of the drugs; (2) serum to be used as a matrix for the drugs; (3) techniques for achieving homogeneity and stability of the SRM; and (4) two independent, highly accurate analytical methods for the certification. This document describes development of methods and procedures used to produce and certify the SRM.