DEVELOPMENT AND VALIDATION OF A SENSITIVE METHOD FOR THE DETERMINATION OF GANCICLOVIR IN HUMAN PLASMA SAMPLES BY REVERSED-PHASE HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHY

A rapid, sensitive, specific liquid chromatographic method has been de veloped for the determination of therapeutic levels of ganciclovir in human plasma. Plasma (1 mi) and acyclovir (I.S.) were treated with 50% trichloroacetic acid. The supernatant was neutralized with 2 M NaOH a nd purified with chloroform. The aqueous phase (80 mu l) was analyzed by a 3-mu m Hypersil ODS C-18 column with 0.04 M triethylamine-0.1 M s odium dihydrogen phosphate monohydrate as the mobile phase (1 ml/min) and ultraviolet detection at 254 nm. Calibration was linear from 50 to 10 000 ng/ml. Intra-and inter-day C.V. did no exceed 6.65%. The detec tion limit was about 10 ng/ml. (C) 1998 Elsevier Science B.V.