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离子色谱法测定酒石酸沃尼妙林中酒石酸的含量

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建立离子色谱-抑制电导检测法测定化学对照品中酒石酸盐的含量.以酒石酸沃尼妙林对照品为例,采用Dionex IonPacTM AS19(4×250 mm)阴离子交换色谱柱和Dionex IonPacTM AG18(4×50 mm)保护柱,以22 mmol/L氢氧化钾溶液为流动相,流速为1.0 mL/min等度洗脱,抑制电导检测器检测,测定酒石酸盐中酒石酸的含量.结果表明,该方法在1.0~50 μg/mL浓度范围内线性关系良好(r =0.999),定量限为 0.5 μg/mL,酒石酸沃尼妙林在 3 个水平的加样回收率分别为98·79%、98.91%与96.50%,平均回收率为98.07%(RSD =2.20%,n =9).用此方法测定3 个厂家共5 批样品,酒石酸沃尼妙林中酒石酸含量的数值与理论值基本一致.本文建立的离子色谱法准确、灵敏,可用于酒石酸盐成盐比例与含量的测定.
Determination of Tartaric Acid in Valnemulin Hydrogen Tartrate by Ion Chromatography
To establish an ion chromatography method with suppressed conductivity detection for the tartaric acid determination in the chemical reference standards the tartaric acid content of valnemulin hydrogen tartrate was determined by an Dionex IonPacTM AS19(4×250 mm)anion exchange column and Dionex IonPacTM AG18(4×50 mm)guard column,using suppressed conductivity detector.An isocratic eluent of 22 mmol/L KOH was chosen as mobile phase,flow rate was1.0 mL/min.Results manifested that a good linear relationship was observed within the range of 1.0~50.0 μg/mL(r =0.999,n =6).The limit of quantification was 0.5 μg/mL.The average spiked recovery was 98.07%at three concentration levels with RSD of 2.20%(n =9).Five batches of in valnemulin hydrogen tartrate samples from 3 manufactures were tested using this validated method,and the contents of tartaric acid were basically consistent with the theoretical values.The method is accurate and sensitive,which provides a reliable analytical method for the control of the proportion and content of the tartaric acid salts.

ion chromatographychemical reference standardstartaric acidvalnemulin hydrogen tartrate

张骊、王轩、赵晖、沈昕、王鹤佳、顾进华、朱馨乐

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中国兽医药品监察所(农业农村部兽药评审中心),北京 100081

离子色谱法 化学对照品 酒石酸 酒石酸沃尼妙林

中国兽医药品监察所兽药行业公益性重点专项

GY202107

2024

中国兽药杂志
中国兽医药品监察所

中国兽药杂志

CSTPCD
影响因子:0.49
ISSN:1002-1280
年,卷(期):2024.58(3)
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