An Improved Bioanalytical Metho For The Determination Of Fluconazole In Human Plasma And Application In Bioavailability Study

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Date
2010-09
Authors
Yousif, Fadi Ibrahim
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Publisher
Universiti Sains Malaysia
Abstract
Fluconazole is triazole antimycotic agent used in the treatment of oropharyngal, esophageal or vulvovaginal candidiasis and in the treatment of several other systemic candidal infections such as urinary tract infections, peritonitis, candidemia, disseminated candidiasis, meningitis, pneumonia etc. Fluconazole is also used for less severe fungal infections like superficial fungal infections, dermatophytoses and onychomycosis. The objective of the study was to investigate the interaction of food, nasi lemak on the oral absorption of fluconazole. Prior to the comparative pharmacokinetics study of a single oral dose of 150 mg of fluconazole under fasting and fed condition, a simple and sensitive an isocratic HPLC-UV reported method was validated as per the USFDA guidelines for determination of fluconazole in human plasma using phenacetin as an internal standard. Chromatographic separation was achieved isocratically by using a Luna C18 (5 mm, 250 x 4.6 mm ID) (Phenomenex, USA) column. The standard calibration curve exhibited a good linearity with a correlation coefficient of 0.9998. The intra-day accuracy ranged from -9.97% to 0.49% with a precision from 2.15% to 9.23%. The inter-day accuracy ranged from -6.50% to -1.70% with a precision from 2.05% to 7.44%. The LOD was 0.05 μg/ml while the LOQ was 0.20 μg/ml. The influence of food on fluconazole pharmacokinetics was evaluated on 12 healthy male volunteers aged between 22 to 33 years with a single dose (150 mg), two-period, two-sequence, randomized, crossover study design. Washout period was 2-week.
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Keywords
Improved Bioanalytical , Fluconazole In Human Plasma
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