An optimized analytical method of fluconazole in human plasma by high-performance liquid chromatography with ultraviolet detection and its application to a bioequivalence study.
A sensitive and accurate HPLC-UV method for the quantification of fluconazole (FLA) level in human plasma has been developed. The sample was prepared by one-step liquid-liquid extraction (LLE) of FLA from plasma using dichloromethane. Phenacetin was used as the internal standard. The chromatographic retention times of FLA and phenacetin were 4.6 and 8.3 min, respectively. The lower limit of quantitation (LLOQ) was 0.05 microg/mL, and no interferences were detected in the chromatograms. The devised HPLC-UV method was validated by evaluating its intra- and inter-day precisions and accuracies in a linear concentration range between 0.05 and 10.00 microg/mL. The devised method was successfully applied to a bioequivalence studies involving the oral administration of a single 150 mg FLA tablet and 3 x 50 mg FLA capsules in healthy Korean male volunteers.
Kim
Sung-Su
SS
Department of Pharmaceutical Biochemistry and Kyung Hee East-West Pharmaceutical Research Institute, College of Pharmacy, Kyung-Hee University, Hoegi-Dong, Dongdaemun-Gu, Seoul 130-701, Republic of Korea.
Im
Ho-Taek
HT
Kang
Il-Mo
IM
Lee
Hyun-Su
HS
Lee
Heon-Woo
HW
Cho
Sung-Hee
SH
Kim
Jong-Bin
JB
Lee
Kyung-Tae
KT
D000328:Adult; D000935:Antifungal Agents / Q000097:blood* / Q000493:pharmacokinetics; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D015725:Fluconazole / Q000097:blood* / Q000493:pharmacokinetics; D006801:Humans; D008297:Male; D012015:Reference Standards; D012680:Sensitivity and Specificity; D013056:Spectrophotometry, Ultraviolet / Q000379:methods*; D013810:Therapeutic Equivalency
D000935:Antifungal Agents; D015725:Fluconazole