高效液相色谱法测定利巴韦林滴眼液中有关物质的含量

Determination of related compounds in ribavirin eye drops by HPLC

目的建立高效液相色谱法测定利巴韦林滴眼液中有关物质的含量。方法采用Waters Atlantis T3(250 mm×4.6 mm,5μm),以0.1%硫酸钠水溶液(pH=2.8)为流动相A,以乙腈-流动相A(5∶95)为流动相B,以20%乙腈为流动相C,以乙腈为流动相D,梯度洗脱,流速为1.0 mL·min^(-1),柱温为30℃,检测波长为220 nm。结果杂质A回收率在94.6%~100.3%(n=3),校正因子为2.0;未知杂质鉴定为2-磺基苯甲酸。结论该法专属性强、简便可靠,适用于利巴韦林滴眼液有关物质检查,可为其质量控制提供参考。

Objective To establish an HPLC method for the determination of related compounds in ribavirin eye drops.Methods Waters Atlantis T3(250 mm×4.6 mm,5μm)was used.With 0.1%sodium sulfate aqueous solution(pH 2.8)as mobile phase A,acetonitrile-mobile phase A(5∶95)as mobile phase B,20%acetonitrile as mobile phase C,acetonitrile as mobile phase D,and gradient elution at a flow rate of 1.0 mL·min^(-1).The column temperature was 30℃,and the UV detection wavelength was 220 nm.Results The linear correlation coefficient of impurity A was 0.9997,and the average recovery was 94.6%-100.3%(n=3),and the correction factor of impurity A was 2.0.The unknown impurity was identified as 2-sulfobenzonic acid.Conclusion The method is highly specific,simple and reliable,and suitable for the determination of related substances in ribavirin eye drops.