| HPLC法测定盐酸倍他司汀氯化钠注射液的有关物质 |
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| 引用本文： | 许文东,王爱凤,张国锋. HPLC法测定盐酸倍他司汀氯化钠注射液的有关物质[J]. 齐鲁药事, 2006, 25(5): 279-281 |
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| 作者姓名： | 许文东 王爱凤 张国锋 |
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| 作者单位： | 山东齐都药业有限公司技术中心,淄博,255400 |
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| 摘 要： | 目的建立HPLC法测定盐酸倍他司汀氯化钠注射液有关物质的检测和控制方法。方法用CapcellPAKC18色谱柱(250mm×4.6mm,5μm),6.0×10-4mol·L-1的醋酸钠乙腈溶液-0.25%的十二烷基硫酸钠水溶液(40∶60)加1%的二乙胺,用冰醋酸调pH4.5作为流动相,流速为1.0ml·min-1,检测波长为261nm。结果盐酸倍他司汀的最低检出限为3.11ng,盐酸倍他司汀与各杂质峰分离良好。结论方法操作简便、重现性好、灵敏度高、专属性强,可用于盐酸倍他司汀氯化钠注射液的质量控制。
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| 关 键 词： | 高效液相色谱法 盐酸倍他司汀 有关物质 |
| 文章编号： | 1672-7738(2006)05-0279-03 |
Determination of the related substances in Betahistine Hydrochloride Sodium Chloride Injection by HPLC |
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| XU Wen-dong,WANG Ai-feng,ZHANG Guo-feng. Determination of the related substances in Betahistine Hydrochloride Sodium Chloride Injection by HPLC[J]. qilu pharmaceutical affairs, 2006, 25(5): 279-281 |
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| Authors: | XU Wen-dong WANG Ai-feng ZHANG Guo-feng |
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| Abstract: | OBJECTIVE To establish an HPLC method for determination of the related substances in Betahistine Hydrochloride Sodium Chloride Injection.METHOD The HPLC method was performed on Capcell PAK C_ 18 column,6.0×10 -4mol·L -1 sodium acetate in acetonitrile-0.25%Sodium lauryl sulfate(40∶60),adding 1% Diethylamine,adjusting pH to 4.5 with acetic acid,as mobile phase,the flow rate was 1.0ml·min -1,and detection wavelength was set at 261nm.RESULTS The detection limits for Betahistine Hydrochloride was 3.11ng.Good resolution for Betahistine Hydrochloride and related substances was obtained.CONCLUSION The method was simple,highly repeatable,highly sensitive and specific,and can be used for quality control of Betahistine Hydrochloride Sodium Chloride Injection. |
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| Keywords: | HPLC Betahistine Hydrochloride related substances |
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