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Arzneimittelforschung 2008; 58(4): 199-202
DOI: 10.1055/s-0031-1296493
Antibiotics · Antimycotics · Antiviral Drugs · Chemotherapeutics · Cytostatics
Editio Cantor Verlag Aulendorf (Germany)

A Simple High-performance Liquid Chromatographic Method for the Determination of Acyclovir in Human Plasma and Application to a Pharmacokinetic Study

Authors

  • Liyan Yu

    1   Center for Instrumental Analysis, China Pharmaceutical University, Key Laboratory of Drug Quality Control and Pharmacovigilance under the Ministry of Education, Nanjing, (People’s Republic of China)

  • Bingren Xiang

    1   Center for Instrumental Analysis, China Pharmaceutical University, Key Laboratory of Drug Quality Control and Pharmacovigilance under the Ministry of Education, Nanjing, (People’s Republic of China)

  • Ying Zhan

    1   Center for Instrumental Analysis, China Pharmaceutical University, Key Laboratory of Drug Quality Control and Pharmacovigilance under the Ministry of Education, Nanjing, (People’s Republic of China)
Further Information

Publication History

Publication Date:
15 December 2011 (online)

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Abstract

A rapid, simple and sensitive reversed-phase high-performance liquid chromatographic (HPLC) method has been developed for the measurement of acyclovir (CAS 59277-89-3) concentrations in human plasma and its use in bioavailability studies is evaluated. The method was linear in the concentration range of 0.05–4.0 µg/ml. The lower limit of quantification (LLOQ) was 0.05 µg/ml in 0.5 ml plasma sample. The intra- and inter-day relative standard deviations across three validation runs over the entire concentration range were less than 8.2 %. This method was successfully applied for the evaluation of pharmacokinetic profiles of acyclovir capsule in 19 healthy volunteers. The main pharmacokinetic parameters obtained were: AUC0-t 6.50 ± 1.47 and 7.13 ± 1.44 µg . h/ml, AUC0-∞ 6.77 ± 1.48 and 7.41 ± 1.49 µg . h/ml, Cmax 2.27 ± 0.57 and 2.27 ± 0.62 µg/ml, t1/2 2.96 ± 0.41 and 2.88 ± 0.33h, tmax 0.8 ± 0.3 and 1.0 ± 0.5 h for test and reference formulations, respectively. No statistical differences were observed for Cmax and the area under the plasma concentration – time curve for acyclovir. 90 % confidence limits calculated for Cmax and AUC from zero to infinity (AUC0-∞) of acyclovir were included in the bioequivalence range (0.8–1.25 for AUC).

Key words

Acyclovir, bioavailability, chromatography, pharmacokinetics - Antiviral agents - CAS 59277-89-3
 

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