RP-HPLC测定替诺福韦及其有关物质
Determination of the related substances of tenofovir by RP-HPLC
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摘要: 为了研究替诺福韦的有关物质,合成了3个有关化合物,建立了替诺福韦RP-HPLC分离条件(以Agilent ZORBAX SB-C18为色谱柱,以甲醇-0.02 mol/L磷酸二氢钾为流动相梯度洗脱,检测波长为260 nm)。结果显示替诺福韦有3种潜在的有关物质。所建立的分析方法准确度高,重复性好,适用于替诺福韦有关物质的含量检测。Abstract: To investigate the related substances of tenofovir, 3 related substances were synthesized. RP-HPLC analytical method was developed using Agilent ZORBAX SB-C18 column. The mobile phase composed of methanol and 0. 02 mol/L potassium dihydrogen phosphate. Linear gradient elution was used and the detection wavelength was 260 nm. 3 impurities were found in tenofovir. The established method was accurate and reproducible, and it can be applied for the related substances test in tenofovir.
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Keywords:
- tenofovir /
- RP-HPLC /
- related substances /
- impurities
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[1] Van Griensven J,Phirum L,Thai S,et al.A clinical prediction score for targeted creatinine testing before initiating tenofovir-based antiretroviral treatment in Cambodia[J].J Acquir Immune Defic Syndr,2014,65(4):150-152. [2] Mansoor LE,Karim QA,Werner L,et al.Impact of an adherence intervention on the effectiveness of tenofovir gel in the CAPRISA 004 trial[J].AIDS Behav,2014,18(5):841-848. [3] Hu CY,Liu YM,Liu Y,et al.Pharmacokinetics and tolerability of Tenofovir disoproxil fumarate 300 mg once daily:an open-label,single- and multiple-dose study in healthy Chinese subjects[J].Clin Ther,2013,35(12):1884-1889. [4] Custodio JM,Yin X,Hepner M,et al.Effect of food on rilpivirine/emtricitabine/tenofovir disoproxil fumarate,an antiretroviral single-tablet regimen for the treatment of HIV infection[J].J Clin Pharmacol,2014,54(4):378-385.
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