高效液相色谱-示差折光检测器法测定牛磺酸颗粒和滴眼液中牛磺酸含量

Content Determination of Taurine in Taurine Granules and Taurine Eye Drops by High Performance Liquid Chromatography-Refractive Index Detector

目的建立测定牛磺酸颗粒和牛磺酸滴眼液中牛磺酸含量的高效液相色谱-示差折光检测器法。方法色谱柱采用Waters NH2柱(250 mm×4.6 mm,5μm),流动相为水-乙腈(40∶60),流速为0.8 m L/min,柱温为35.0℃,检测器参比池和检测池温度均为35.0℃,进样量为20μL。结果牛磺酸质量浓度在0.05~1.00 g/L(r=0.998 58,n=7)范围内与峰面积线性关系良好,检出限为0.5μg/m L;牛磺酸颗粒和牛磺酸滴眼液的平均回收率分别为100.27%和100.61%,RSD分别为1.26%和1.58%(n=9)。结论该方法可用于牛磺酸颗粒和牛磺酸滴眼液中牛磺酸的质量控制。

Objective To establish a high performance liquid chromatography - refractive index detector（HPLC - RID） method for contentdetermination of taurine in Taurine Granules and Taurine Eye Drops. Methods Waters NH column （250 mm× 4. 6 mm, 5 pm） was adopted,the mobile phase was water - acetonitrile（40： 60） at a flow rate of 0. 8 mL.min, the column temperature was 35.0℃, the temperature of detector reference cell and sample cell were all set at 35. 0 ℃ , the sample size was 20 pL. Results The linear range of taurine was 0.05 -1.00 /L（r = 0.998 58, n =7）, the lower detection limit was 0.5 pg/mL. The avvrage recovery rates of Taurine Granules and Tau-rine Eye Drops were 100.27% and 100.61%, RSDs were 1.26% and 1.58% （ n = 9 ） . Conclusion The method can be used for the quality control of taurine in Taurine Granules and Taurine Eye Drops.