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目的:建立考察自制法匹拉韦片的HPLC含量测定方法。方法:色谱柱为资生堂CAPCELL PAK MGⅡC18(250 mm×4.6 mm,5μm);流动相为0.01 mol·L-1磷酸二氢铵溶液(用三氟乙酸调节p H至3.2):甲醇-乙腈(50∶50)=80∶20;流速为1.0 ml·min-1;检测波长为225 nm;柱温为30℃;进样量为10μl。结果:线性范围为0.040 3~0.120 8 mg·ml-1(r=1.000 0),平均回收率为100.2%,RSD=0.39%(n=9),辅料无干扰。结论:该方法快速准确,重复性好,可用于法匹拉韦片的含量测定。
OBJECTIVE: To establish a method for the determination of HPLC content of self-made ractamivir tablets. Methods: The mobile phase consisted of 0.01 mol·L-1 ammonium dihydrogen phosphate solution (adjusted to pH 3.2 with trifluoroacetic acid) by using a mobile phase of CAPCELL PAK MG Ⅱ C18 (250 mm × 4.6 mm, 5 μm) : 50) = 80:20; the flow rate was 1.0 ml · min-1; the detection wavelength was 225 nm; the column temperature was 30 ℃; Results: The linear range was 0.040 3 ~ 0.120 8 mg · ml-1 (r = 1.000 0). The average recovery was 100.2% and the RSD was 0.39% (n = 9). Conclusion: The method is rapid, accurate and reproducible. It can be used to determine the content of Fabralavir tablets.