反相高效液相色谱法测定富马酸替诺福韦二吡呋酯的有关物质

HPLC Analysis of Related Substance in Tenofovir Disoproxil Fumarate

建立反相高效液相色谱法测定富马酸替诺福韦二吡呋酯中的有关物质。色谱柱为InertsilPhenyl-3,以0.05mol/L醋酸铵缓冲液-乙腈(体积比为97∶3)为流动相A,以0.05mol/L醋酸铵缓冲液-乙腈(体积比为40∶60)为流动相B,梯度洗脱,检测波长260nm。测定结果表明,该法可有效分离主药及降解产物,分离度达到1.5以上,破坏性试验主峰纯度的纯度因子均大于阈值980,可见峰纯度良好。该方法用来测定富马酸替诺福韦二吡呋酯中的有关物质结果准确、可靠。

We established an HPLC determination method to analyze the related substance of tenofovir disoproxil fumarate. The HPLC on pack Inertsil Phenyl-3 （4. 6 mm× 100 mm,3 μm） was adopted; the mobile phase consisted of a mixture of 0.05 mol/L ammonium acetate buffer so- lution-acetonitrile（mass ratio of 97： 3） as mobile phase A, and a mixture of 0.05 mol/L ammoni- um acetate buffer solution-acetonitrile（mass ratio of 40：60） as mobile phase B. Gradient elution was used. The wavelength was set at 260 nm. The results show that this method can effectively separate the main drug from degradation products; the separation degree is 1.5 or more, and the destructive testing of the main peak purity factor is greater than the threshold value 980 with good visible peak purity. Besides, the proposed method is simple and accurate.