Bioequivalence evaluation of two brands of cefaclor 500 mg capsules: quantification of cefaclor using solid phase extraction technique

生物等效性 头孢克洛 最大值 色谱法 药代动力学 高效液相色谱法 固相萃取 萃取(化学) 交叉研究 化学 药理学 医学 安慰剂 生物化学 头孢菌素 病理 替代医学 抗生素
作者
Maha Tutunji,O. Jarrar,M. Musameh,S. Mahmood Alam,R. Dham
出处
期刊:Journal of Clinical Pharmacy and Therapeutics [Wiley]
卷期号:26 (2): 149-153 被引量:10
标识
DOI:10.1046/j.1365-2710.2001.00337.x
摘要

To assess the bioequivalence of two cefaclor 500 mg capsule formulations, and to develop a new high performance liquid chromatographic (HPLC) method using solid phase extraction technique for the quantification of cefaclor in human plasma.An open, randomized, two-way, crossover trial with a one-week washout period in 25 healthy volunteers. The two commercial brands used were Recocef(Julphar, United Arab Emirates) as test and Ceclor(Eli Lilly, UK) as reference product. The drug was administered with 240 mL of water after a 10-h overnight fast. After dosing, serial blood samples were collected for a period of 8 h. Plasma harvested from blood was analysed for cefaclor by a new HPLC method using a solid phase extraction technique. The limit of detection of cefaclor was 17.6 ng/mL; average recovery was 96.5%; the intraday CV was less than 8% and interday CV was less than 13%. Various pharmacokinetic parameters, including AUC0-t, AUC0-infinity, Cmax, Tmax, T1/2, and Kel, were determined from plasma concentrations for both formulations. Statistical analysis (ANOVA and 90% confidence intervals) were applied to AUC0-t, AUC0-infinity and Cmax for bioequivalence evaluation of two brands. The new HPLC method with solid phase extraction circumvented the problem of mixed polarity of cefaclor and facilitated its extraction from the complex plasma matrix while keeping the background free from interference due to endogenous plasma compounds.No significant difference was observed between the two brands of cefaclor capsules.Recocef was judged bioequivalent to Ceclor and the two products can therefore be considered to be interchangeable in medical practice.
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