目的 建立高效液相色譜-示差折光檢測器（HPLC-RID）法測定?；撬犷w粒中牛磺酸。方法 采用Welch Ultimate HILIC Amide色譜柱（250 mm×4.6 mm，5 μm），以0.1%冰醋酸–乙腈（30∶70）為流動相，柱溫為30 ℃，示差折光檢測器溫度30 ℃，體積流量1.0 mL/min，進樣體積20 μL。結(jié)果 ?；撬嵩?.008～1.211 mg/mL與峰面積呈良好線性關(guān)系，平均回收率為99.9%，RSD值為0.7%。結(jié)論 本法測定準確、可靠、專屬性強，為牛磺酸制劑的測定提供新的檢測方法。

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

國家藥品標準制修訂研究課題(2021H032)