Validated HPLC method for the determination of fluconazole in human plasma

被引:35
作者
Wattananat, T [1 ]
Akarawut, W [1 ]
机构
[1] Bur Drugs & Narcot, Dept Med Sci, Minist Publ Hlth, Nonthaburi 11000, Thailand
关键词
fluconazole; HPLC; UV detection;
D O I
10.1002/bmc.538
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
A high-performance liquid chromatographic assay with UV detection was developed for the determination of fluconazole in human plasma. The method utilized solid-phase extraction for sample clean-up. The separation was performed on a C, column by isocratic elution with a mobile phase of 10 mm acetate buffer at pH 5.0 and methanol and UV detection at 210 nm. Validation was performed according to the current recommendations of the USFDA bioanalytical method validation guidance. The method proved to be specific, accurate, precise and linear between 200 and 10,000 ng/mL with correlation coefficients greater than 0.999. The coefficient of variation was within 11% and relative deviation was less than 10%. Copyright (c) 2005 John Wiley & Sons, Ltd.
引用
收藏
页码:1 / 3
页数:3
相关论文
共 12 条
[1]   High-performance liquid chromatographic determination of fluconazole in plasma [J].
Cociglio, M ;
Brandissou, S ;
Alric, R ;
Bressolle, F .
JOURNAL OF CHROMATOGRAPHY B-BIOMEDICAL APPLICATIONS, 1996, 686 (01) :11-17
[2]   DETERMINATION OF FLUCONAZOLE IN BIOLOGICAL-FLUIDS BY CAPILLARY COLUMN GAS-CHROMATOGRAPHY WITH A NITROGEN DETECTOR [J].
DEBRUYNE, D ;
RYCKELYNCK, JP ;
BIGOT, MC ;
MOULIN, M .
JOURNAL OF PHARMACEUTICAL SCIENCES, 1988, 77 (06) :534-535
[3]   RAPID-DETERMINATION OF SERUM LEVELS OF A NEW ANTIFUNGAL AGENT, FLUCONAZOLE, BY HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHY [J].
HOSOTSUBO, KK ;
HOSOTSUBO, H ;
NISHIJIMA, MK ;
OKADA, T ;
TAENAKA, N ;
YOSHIYA, I .
JOURNAL OF CHROMATOGRAPHY-BIOMEDICAL APPLICATIONS, 1990, 529 (01) :223-228
[4]   DETERMINATION OF FLUCONAZOLE IN HUMAN SERUM BY SOLID-PHASE EXTRACTION AND REVERSED-PHASE HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHY [J].
INAGAKI, K ;
TAKAGI, J ;
LOR, E ;
OKAMOTO, MP ;
GILL, MA .
THERAPEUTIC DRUG MONITORING, 1992, 14 (04) :306-311
[5]   Pharmacokinetics of fluconazole in saliva and plasma after administration of an oral suspension and capsules [J].
Koks, CHW ;
Meenhorst, PL ;
Hillebrand, MJX ;
Bult, A ;
Beijnen, JH .
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 1996, 40 (08) :1935-1937
[6]   Sensitive bioassay for determination of fluconazole concentrations in plasma using a Candida albicans mutant hypersusceptible to azoles [J].
Marchetti, O ;
Majcherczyk, PA ;
Glauser, MP ;
Bille, J ;
Moreillon, P ;
Sanglard, D .
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 2001, 45 (03) :696-700
[7]   On-line determination of fluconazole in blood and dermal rat microdialysates by microbore high-performance liquid chromatography [J].
Mathy, FX ;
Vroman, B ;
Ntivunwa, D ;
De Winne, AJ ;
Verbeeck, RK ;
Préat, W .
JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES, 2003, 787 (02) :323-331
[8]   STANDARDIZATION OF A FLUCONAZOLE BIOASSAY AND CORRELATION OF RESULTS WITH THOSE OBTAINED BY HIGH-PRESSURE LIQUID-CHROMATOGRAPHY [J].
REX, JH ;
HANSON, LH ;
AMANTEA, MA ;
STEVENS, DA ;
BENNETT, JE .
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 1991, 35 (05) :846-850
[9]   EFFICACY OF UK-49,858 (FLUCONAZOLE) AGAINST CANDIDA-ALBICANS EXPERIMENTAL INFECTIONS IN MICE [J].
TROKE, PF ;
ANDREWS, RJ ;
BRAMMER, KW ;
MARRIOTT, MS ;
RICHARDSON, K .
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 1985, 28 (06) :815-818
[10]  
USFDA, 2001, GUID IND BIOAN METH