建立UPLC法测定复方氨基酸胶囊(9-5)中氨基酸的含量  

Measuring the content of amino acid in compound amino acid capsules(9-5) by establishing the method of UPLC

作　　者：翁燕[1] 刘丽娜 周小燕 谌杰亮 

机构地区：[1]南京中医药大学附属医院,南京210029 [2]南京圣和药业有限公司,南京210038 [3]中国药科大学,南京210009

出　　处：《实用药物与临床》2017年第2期202-207,共6页Practical Pharmacy and Clinical Remedies

摘　　要：目的通过优化色谱条件建立UPLC法测定复方氨基酸胶囊(9-5)中氨基酸的含量。方法以9种氨基酸对照为外标物,异硫氰酸苯酯为柱前衍生剂,采用ACQUITY UPLCBEH C_(18)(2.1 mm×100 mm,1.7μm)柱,流动相A为0.1 mol/L的醋酸钠溶液(用冰醋酸调整pH至6.50)-乙腈(93∶7),流动相B为乙腈-水(4∶1),检测波长254 nm,流速为0.45 mL/min,柱温36℃。结果复方氨基酸胶囊(9-5)中9种氨基酸出峰时间与对照品出峰时间一致,其他物质无干扰;仪器精密度RSD为0.5%~1.2%,中间精密度RSD为1.3%~1.9%;各氨基酸的溶液浓度与其峰面积线性关系良好(r≥0.999),溶液稳定性RSD为0.6%~1.8%,各氨基酸的平均回收率在95.0%~105.0%之间。含量测定方法比对实验中UPLC法与HPLC法分析结果无明显差异,分析速度明显提高。结论建立的UPLC法高效,快速,灵敏,准确,可用于测定复方氨基酸胶囊(9-5)中氨基酸的含量。Objective Optimal method of UPLC was established to measure the content of amino acid in compound amino acid capsules by detailed investigation of Chromatographic parameters.Methods Nine kinds of amino acids were external standard,with phenyl isothiocyanate as the derivatization agent.Use ACQUITY UPLC BEH C18（2.1 mm×100 mm,1.7 μm） column.The mobile phase A was 0.1 mol/L sodium acetate solution（adjusted with acetic acid to pH 6.50）-acetonitrile（93：7）;and acetonitrile-solution（4：1） was the mobile phase B.The detection wavelength was 254 nm;the flow rate was 0.45 mL/min;the column temperature was 36 ℃.Results The peak time of nine kinds of amino acids in Compound amino acid capsule（9-5） was the same as that of reference substance.There was no interference for other ingredients.RSD of instrument precision was 0.5%~1.2%,and intermediate precision RSD was 1.3%~1.9%＇,there was a good linear relationship of nine kinds of amino acids in different concentrations（r≥0.999）;the stability of solution RSD was 0.6%~ 1.8%;the average recovery of each kind of amino acid rate was95.0%~105.0%.There was no obvious difference between the method of UPLC and HPLC based on the content determination.UPLC improved the speed of analysis significantly.Conclusion The method of UPLC can be used for measuring the content of amino acid in compound amino acid capsules（9-5）,which is efficient and accurate.

关 键 词：异硫氰酸苯酯 复方氨基酸胶囊(9-5) UPLC 氨基酸 方法学验证 

分 类 号：R927.2[医药卫生—药学] O657.72[理学—分析化学]