Determination of xylitol in compound amino acid injection(18AA-V)by ion-suppression chromatography
肖菁 1左利民 2谷永升 3赵婷 2连晓芳 2刘惠一 2王蓉蓉 1周怡 4山广志2
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作者信息
1. 湖南省药品检验检测研究院,长沙 410001
2. 中国医学科学院医药生物技术研究所,北京 100050
3. 新疆医科大学药学院,乌鲁木齐 830017
4. 国家药典委员会,北京 100061
折叠
摘要
目的 建立离子抑制色谱法测定复方氨基酸注射液(18AA-V)中木糖醇的含量.方法 采用 HyperREZ XP Carbohydrate H+色谱柱(7.7 mm × 300 mm,8μm),以 12.5× 10-3 mol·L-1硫酸溶液为流动相,等度洗脱,流速为0.5 mL·min-1,柱温为55℃,检测波长为200 nm.结果 木糖醇峰和相邻色谱峰分离度良好,在5.002～20.01 mg·mL-1内与峰面积线性良好(r=0.9997,n=5),精密度、重复性、稳定性试验的RSD均＜1.0％,低、中、高浓度的回收率分别为99.10％、97.86％和96.82％,RSD分别为1.9％、1.7％和0.5％(n=3).3批复方氨基酸注射液(18AA-V)中木糖醇含量分别为标示量的96.96％、97.25％、97.32％.结论 该方法可有效解决氨基酸成分的干扰,快速简便、专属性强、准确度高,可用于复方氨基酸注射液(18AA-V)中木糖醇的含量测定.
Abstract
Objective To determine xylitol in compound amino acid injection(18AA-V)by ion-suppression chromatography method.Methods A HyperREZ XP Carbohydrate H+column(7.7 mm×300 mm,8 μm)was used,with 12.5 × 10-3 mol·L-1 sulfuric acid as the mobile phase,isocratic elution at a flow rate of 0.5 mL·min-1,with the column temperature of 55 ℃,and detection wavelength of 200 nm.Results The xylitol peak and the adjacent peaks were well separated,with good linearity(r=0.9997,n=5)at 5.002～20.01 mg·mL-1.The RSDs of precision,reproducibility,and stability were all＜1.0％,The recovery of low,medium,and high concentrations were 99.10％,97.86％,and 96.82％,respectively,with RSDs of 1.9％,1.7％,and 0.5％,respectively(n=3).The content of xylitol in three batches of compound amino acid injection(18AA-V)was 96.96％,97.25％and 97.32％respectively of the labeled amount.Conclusion The method can effectively reduce the interference of amino acid components rapidly and simply,with high specificity and accuracy,and can be used for the content determination of xylitol in compound amino acid injection(18AA-V).
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