目的 建立高效液相色谱-示差折光检测器（HPLC-RID）法测定牛磺酸颗粒中牛磺酸。方法 采用Welch Ultimate HILIC Amide色谱柱（250 mm×4.6 mm，5 μm），以0.1%冰醋酸–乙腈（30∶70）为流动相，柱温为30 ℃，示差折光检测器温度30 ℃，体积流量1.0 mL/min，进样体积20 μL。结果 牛磺酸在0.008～1.211 mg/mL与峰面积呈良好线性关系，平均回收率为99.9%，RSD值为0.7%。结论 本法测定准确、可靠、专属性强，为牛磺酸制剂的测定提供新的检测方法。

Objective To establish an HPLC-RID method for determination of taurine in Taurine Granules. Methods Welch Ultimate HILIC Amide column (250 mm×4.6 mm, 5 μm) was used. The mobile phase was 0.1% glacial acetic acid-acetonitrile (30∶70). The column temperature was 30 ℃, and the differential refractive detector temperature was 30 ℃. The volume flow rate was 1.0 mL/min, and the injection volume was 20 μL. Results Taurine had good linear relationships of 0.008—1.211 mg/mL, and the average recovery rate was 99.9% with RSD 0.7%. Conclusion This method is accurate, reliable, and highly specific, which provides a new detection method for the determination of taurine preparations.

R286.02

国家药品标准制修订研究课题(2021H032)