来自中国的自信，月旭Welchrom® C18测定拉米夫定有关物质 除非经大量试验比较市面主流厂家的色谱柱均不能达到要求，最好不要把色谱柱的品牌定下来。 拉米夫定（Lamivudine）对乙型肝炎病毒和HIV有明显的抑制作用。口服吸收后，拉米夫定可在HIV感染细胞和正常细胞内代谢生成拉米夫定三磷酸盐，它是拉米夫定的活性形式。后者通过竞争抑制作用，终止DNA链的延长，从而抑制HIV和HBV的反转录酶和HBV聚合酶，阻止HIV和HBV的DNA合成和病毒复制。体外实验中与齐多夫定联合，对HIV病毒有协同作用。 下面为中国药典2015年版收载的质量标准，其中提到的色谱柱，我们咨询了价格比较贵，我们就用手上的月旭色谱柱进行了探索研究。参照了EP8.0质量标准，进行了系统适用性试验，其中EP8.0质量标准有关物质项下为： Related substances. Liquid chromatography (2.2.29). Test solution. Dissolve 50.0 mg of the substance to be examined in the mobile phase and dilute to 100.0 mL with the mobile phase. Reference solution (a). Dilute 1.0 mL of the test solution to 100.0 mL with the mobile phase. Dilute 1.0 mL of this solution to 10.0 mL with the mobile phase. Reference solution (b). Dissolve 5 mg of salicylic acid R in the mobile phase and dilute to 100.0 mL with the mobile phase. Dilute 1.0 mL of the solution to 100.0 mL with the mobile phase. Reference solution (c). Dissolve 50.0 mg of lamivudine CRS in the mobile phase and dilute to 100.0 mL with the mobile phase. Reference solution (d). Dissolve 5 mg of cytosine R and 5 mg of uracil R in the mobile phase and dilute to 100.0 mL with the mobile phase. Dilute 2.0 mL of the solution to 10.0 mL with the mobile phase. Reference solution (e). Dissolve 5 mg of lamivudine for system suitability 1 CRS (containing impurities A and B) in 2 mL of the mobile phase. Add 1.0 mL of reference solution (d) and dilute to 10.0 mL with the mobile phase. Column: - size: l = 0.25 m, Ø = 4.6 mm; - stationary phase: base-deactivated octadecylsilyl silica gel for chromatography R (5 μm); - temperature: 35 °C. Mobile phase: mix 5 volumes of methanol R and 95 volumes of a 1.9 g/L solution of ammonium acetate R, previously adjusted to pH 3.8 with glacial acetic acid R. Flow rate: 1.0 mL/min. Detection: spectrophotometer at 277 nm. Injection: 10 μL. Run time: 3 times the retention time of lamivudine. Identification of impurities: use the chromatograms obtained with reference solutions (b) and (e) to identify the peaks due to impurities A, B, E, F and C. Relative retention with reference to lamivudine (retention time = about 9 min): impurity E = about 0.28; impurity F = about 0.32; impurity A = about 0.36; impurity B = about 0.91; impurity J = about 1.45; impurity C = about 2.32. System suitability: reference solution (e): - resolution: minimum 1.5 between the peaks due to impurities F and A; minimum 1.5 between the peaks due to impurity B and lamivudine. Limits: - correction factors: for the calculation of content, multiply the peak areas of the following impurities by the corresponding correction factor: impurity E = 0.6; impurity F = 2.2; impurity J = 2.2; - impurity A: not more than 3 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.3 per cent); - impurity B: not more than twice the area of the principal peak in the chromatogram obtained with reference solution (a) (0.2 per cent); - impurity C: not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (0.1 per cent); any other impurity: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (a) (0.1 per cent); - total: not more than 6 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.6 per cent); - disregard limit: 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.05 per cent). 中文名拉米夫定外文名lamivudine CAS号134678-17-4分子式C8H11N3O3S 以上均为参照中国药典2015年收载的拉米夫定片质量的截图，然后进行系统适用性试验，进行流动相微调，其典型色谱图见下图： 初步统计色谱峰保留时间，其他色谱图参数很好，理论板数都超级好，分离度和拖尾因子也超级好！
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