Quantitation of vancomycin and its crystalline degradation product (CDP-1) in human serum by high performance liquid chromatography.

The delayed clearance of vancomycin results in accumulation of vancomycin crystalline degradation product, CDP-1, in the bodies of renally impaired patients. The 2 isomers, CDP-1-M (major) and CDP-1-m (minor), of CDP-1 are antibiotically inactive but cross-react with some immunoassays that use polyclonal antibodies resulting in falsely elevated results. A high performance liquid chromatographic (HPLC) method was developed to quantitate vancomycin and CDP-1 in the serum of renal patients. After solid phase extraction of 200 microliters serum, the separation of vancomycin, the 2 isomers of CDP-1 and the internal standard (cefazolin) was accomplished by gradient HPLC on a reversed phase C18 column with detection at 210 nm. Linearity was established from 1 to 25 and 25 to 100 micrograms ml-1 vancomycin and 1 to 25 micrograms ml-1 CDP-1. Coefficients of variation for vancomycin and CDP-1 were 3.3-8.6% (n = 10) and 2.8-5.2% (n = 8).