A high performance liquid chromatography method for the quantitative determination of erlotinib in the plasma of tumor bearing BALB/c nude mice and its application in a pharmacokinetic study

doi:10.5246/jcps.2011.03.030

Abstract

Abstract:

A new HPLC-UV method was developed and validated for the quantitative determination of epidermal growth factor receptor inhibitor erlotinib in the plasma of tumor bearing BALB/c nude mice. Erlotinib and its internal standard 1-(3-((6,7-bis (2-methoxyethoxy) quinazolin-4-yl) amino) phenyl) ethanone were extracted from mice plasma samples using liquid-liquid extraction with a mixed solvent of methyl t-butyl ether and ethyl acetate (9:1, v/v). Chromatographic separation was performed on a Luna C18 column (4.6 mm×250 mm, 5 μm) with acetonitrile: 5 mM potassium phosphate buffer pH = 5.2 (41:59, v/v) as the mobile phase. UV detector was set at the wavelength of 345 nm, and the flow rate was 1.0 mL/min. The calibration curve was linear over the range of 20-10 000 ng/mL with acceptable intra- and inter-day precision and accuracy. The intra-day and inter-day precisions were within the range of 1.69%-5.66%, and the accuracies of intra- and inter-day assays were within the range of 105%-113%. The mean recoveries were 85.2% and 96.1% for erlotinib and IS, respectively. This method was successfully applied to a pharmacokinetic study in tumor bearing BALB/c nude mice following single oral administration at the dose of 12.5 mg/kg. The main pharmacokinetic parameters were as follows: Cmax was 4.67 μg/mL, Tmax was 1.0 h, T1/2 was 2.78 h, and AUC0-24 h was 18.0 μg/mL∙h.

Key words: Erlotinib, HPLC-UV, Liquid-liquid extraction, Pharmacokinetics, Epidermal growth factor receptor, Tumor

CLC Number:

R969.1

Supporting:

Han-Qing Li, Ye Chen, Zai-Quan Li, Chen-Hui Deng, Liang Li, Shan-Shan Bi, Meng-Yao Li, Tian-Yan Zhou^*, Wei Lu^* . A high performance liquid chromatography method for the quantitative
determination of erlotinib in the plasma of tumor bearing BALB/c nude
mice and its application in a pharmacokinetic study[J]. , DOI: 10.5246/jcps.2011.03.030.

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A high performance liquid chromatography method for the quantitative
determination of erlotinib in the plasma of tumor bearing BALB/c nude
mice and its application in a pharmacokinetic study

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