目的 建立同时测定复方氨基酸注射液（20AA）中焦谷氨酸、醋酸根的HPLC方法。方法 采用GL Sciences Inertsil ODS-3色谱柱（250 mm×4.6 mm，5 μm）；流动相：乙腈–5 mmol/L磷酸溶液（磷酸调pH 2.5），采用梯度洗脱；检测波长：210 nm；体积流量：1.0 mL/min；柱温：25 ℃；进样量：15 μL。结果 在上述色谱条件下，焦谷氨酸、醋酸根峰与各自相邻峰的分离度均大于2.0；焦谷氨酸和醋酸根的定量限分别为0.10、0.99 μg/mL，检测限分别为0.03、0.30 μg/mL；焦谷氨酸和醋酸根分别在0.1～120.0 μg/mL、0.6～540.0 μg/mL与峰面积呈良好的线性关系。焦谷氨酸和醋酸根的回收率分别为100.04%、98.39%，RSD值分别为0.12%、0.70%。结论 本方法简便、灵敏度高、重现性好，适用于复方氨基酸类制剂中焦谷氨酸和醋酸根的同时检测。

Objective To establish an HPLC method for simultaneous determination of pyroglutamic acid and acetate ion in Compound Amino Acid Injection (20AA). Methods GL Sciences Inertsil ODS-3 column (250 mm×4.6 mm, 5 μm) was used. The mobile phase consisted of acetonitrile and 5 mmol/L phosphoric acid solution (pH 2.5). The determination was performed by gradient elution. The detection wavelength was set at 210 nm. The flow rate was 1.0 mL/min; the volume of injection was 15 μL, and the temperature of column was set at 25 ℃. Results The resolutions of pyroglutamic acid and acetate ion with their own closely eluting peaks were both good with R > 2.0. The LOQs of pyroglutamic acid and acetate ion were 0.10 and 0.99 μg/mL, respectively. The LODs were 0.03 and 0.30 μg/mL, respectively. Pyroglutamic acid and acetate ion had good linearity in the range of 0.1 — 120.0 μg/mL and 0.6 — 540.0 μg/mL, respectively. The average recoveries were 100.04% and 98.39%, with RSD values of 0.12% and 0.70%, respectively. Conclusion The method is simple and convenient, and has high sensitivity and good reproducibility, and is suitable for the simultaneous determination of pyroglutamic acid and acetate ion in compound amino acid prescriptions.

R927.2

国家自然科学基金面上项目（31970667）；重大新药创制国家科技重大专项（2019ZX09721001-006-001）；国家药典委员会药品标准制修订研究课题（2019H03）；天津市“131”创新型人才培养工程项目