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[摘要]
目的 建立以氫氧根作為淋洗液的離子色譜法測定復(fù)方氨基酸注射液(20AA)中醋酸根的方法。方法 使用Dionex ICS 3000離子譜儀,Dionex As19-Ag19陰離子交換色譜柱(250 mm×4 mm),水–30 mmol/L氫氧化鈉溶液為淋洗液,梯度洗脫,體積流量1.0 mL/min,柱溫30 ℃,進(jìn)樣量20 μL,抑制型電導(dǎo)檢測器,檢測池溫度35 ℃。結(jié)果 醋酸根與相鄰雜質(zhì)的分離度為1.8,最低檢出濃度0.75 μmol/L,線性范圍0.75~2.24 mmol/L(r=0.999 5),平均回收率為100.7%,RSD值為1.7%。結(jié)論 該方法操作簡單,分離度好,背景低,是控制復(fù)方氨基酸注射液(20AA)中醋酸根的可靠方法。
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[Abstract]
Objective To establish a method for the determination of acetate ion in Compound Amino Acid Injection (20AA) by ion chromatography with hydroxide as mobile phase. Methods Determination was carried out on Dionex As19-Ag19 anion-exchange chromatography column (250 mm × 4 mm) with Dionex ICS 3000 Ion Spectrometer. The elutriant consisted of water-30 mmol/L sodium hydroxide with gradient elution at a flow rate of 1.0 mL/min. The temperature of column was set at 30 ℃ with injection volume of 10 μL. Inhibitory electrical conductivity detector was used with detecting pool temperature of 35 ℃. Results The resolution between acetate ion peak and adjacent peak was 1.8, and LOD was 0.75 μmol/L. The calibration curve was linear in the range of 0.75 — 2.24 mmol/L (r = 0.999 5). The recovery was 100.7% with RSD value of 1.7% (n = 9). Conclusion The method is simple with good resolution and low background, and can be used for quality control of acetate ion in Compound Amino Acid Injection (20AA).
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