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HPLC测定穿琥宁注射液中的有关物质
引用本文:杨蕾,孔遥,袁军. HPLC测定穿琥宁注射液中的有关物质[J]. 华西药学杂志, 2012, 27(4): 445-446
作者姓名:杨蕾  孔遥  袁军
作者单位:1. 四川省食品药品检验所,四川成都,611731
2. 安捷伦科技中国有限公司,四川成都,610012
摘    要:目的 采用HPLC法测定穿琥宁注射液中的有关物质.方法 采用Inertsil ODS -3色谱柱(250mm×4.6mm,5μm),流动相为甲醇-0.2%甲酸(7∶3),检测波长251 nm,柱温35℃.结果 主成分与有关物质可完全分离,杂质1、杂质2的相对校正因子和相对保留时间分别为0.92、0.90和0.8、0.9 min,检测限为0.2 μg· mL-1.结论 所用方法灵敏、专属、准确.

关 键 词:穿琥宁  有关物质  高效液相色谱法

Determination of the related substances of Potassinm dehydroandrographolide succinate injection by HPLC
YANG Lei , KONG Yao , YUAN Jun. Determination of the related substances of Potassinm dehydroandrographolide succinate injection by HPLC[J]. West China Journal of Pharmaceutical Sciences, 2012, 27(4): 445-446
Authors:YANG Lei    KONG Yao    YUAN Jun
Affiliation:1(1.Sichuan Institute for Food and Drug Control,Chengdu,Sichuan,610097 P.R.China;2.Agilent Technologies(China)Co.,Ltd.,Chengdu,Sichuan,610012 P.R.China)
Abstract:OBJECTIVE To detect the related substances in Potassinm dehydroandrographolide succinate injection by HPLC.METHODS Inertsil ODS-3 column(250 mm×4.6 mm,5 μm)was used.The mobile phase consisted of acetonitrile-2%formic acidwater(7:3).The detective wavelength was 251 nm and the column temperature maintained at 35 ℃.RESULTS Principal component and related substances could be completely separated.The relative corrections factor of impurity 1 and impurity 2 were 0.92,0.90,and the relative retention times of impurity 1 and impurity 2 were 0.8,0.9,respectively.The limit of quantitation was 0.2 μg·mL~-1.CONCLUSION The method is sensitive,specific,accurate.
Keywords:Potassinm dehydroandrographolide succinate injection  Related substances  HPLC
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