HPLC法测定达卡他韦原料药的含量及有关物质

Content and Impurity Determination of DCL by HPLC

目的:采用HPLC法测定达卡他韦的含量及有关物质。方法:采用色谱柱Spursil-C18(25 cm×4.6 mm×5μm)为色谱柱,以0.01MKH2PO4∶TEA=1000∶0.5(H3PO4调pH为3.0)溶液为流动相A,乙腈为流动相B,以流动相A∶流动相B(70∶30)梯度洗脱,流速为1.0m L/min。稀释液为水∶乙腈=70∶30,检测波长为304 nm,柱温为35℃。结果:达卡他韦的线性范围为80~120μg/m L,3批样品中达卡他韦的含量分别为100.42%、100.29%、100.38%;有关物质A-C的线性范围分别为0.015%~0.30%。结论:本方法简便、准确,适用于达卡他韦含量及有关物质的测定。

Objective： To establish an HPLC method for assay determination of DCL. Method： adopt column Spursil-C18（25 cm×4.6 mm×5 μm） as analytical column, 0.01 MKH2 PO4：TEA=1000：0.5（H3 PO4 pH=3.0） solution as mobile phase A, Acetonitrile as mobile phase B, gradient elute mobile phase A and mobile phase B（70∶30）at a flow rate of 1.0 m L/min. The dilution should be water and Acetonitrile（70∶30） at the wavelength of 304 nm at the temperature of 35 ℃. Result： The linear range of DCL is 80-120 μg/m L, The linear range of Impurity A-C is 0.015 %-0.30 %, the DCL assay of 3 batches samples is 100.42 %, 100.29 %, 100.38 % respectively. Conclusion： above method is simple, accurate which is suitable for the assay and imputity determination of DCL.