| 高效液相色谱法测定氨甲苯酸注射液的含量及有关物质 |
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| 引用本文： | 朱迎军,兰文,王伟娇. 高效液相色谱法测定氨甲苯酸注射液的含量及有关物质[J]. 中南药学, 2012, 10(4): 263-265 |
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| 作者姓名： | 朱迎军 兰文 王伟娇 |
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| 作者单位： | 湖南省食品药品检验研究院,长沙,410001 |
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| 摘 要： | 目的 采用HPLC法测定氨甲苯酸注射液的含量及有关物质.方法 色谱柱:氨基键合硅胶柱(Boston Green Amino-NH2,4.6 mm×250 mm,5μm)；流动相:乙腈-0.04％醋酸钠溶液(氢氧化钠调pH至7.4)(70 ∶30)；检测波长:230nm;流速:1.0mL·min-1;进样量:10μL；柱温:30℃.结果 在该色谱条件下,氨甲苯酸注射液在0.03～0.4 mg·mL-1具有良好的线性关系(r=1)；平均回收率为99.9％,RSD为0.05％(n=9).结论 本法简便、快速、准确,专属性好,为氨甲苯酸注射液含量及有关物质质量标准的修订提供了依据.
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| 关 键 词： | 氨甲苯酸注射液 高效液相色谱法 含量测定 有关物质 |
Determination of aminomethylbenzoic acid injection and related substances by HPLC |
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| ZHU Ying-jun , LAN Wen , WANG Wei-jiao. Determination of aminomethylbenzoic acid injection and related substances by HPLC[J]. Central South Pharmacy, 2012, 10(4): 263-265 |
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| Authors: | ZHU Ying-jun LAN Wen WANG Wei-jiao |
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| Affiliation: | (Hunan Institute for Food and Drug Control,Changsha 410001) |
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| Abstract: | Objective To establish an HPLC method to determine the content of aminomethylbenzoic acid and related substances.Methods The separation was performed on Boston Green Amino-NH2(4.6 mm×250 mm,5 μm).The mobile phase was composed of acetonitrile-0.04% sodium acetate aqueous(pH being adjusted to 7.4 with NaOH)(70∶30).The flow rate was 1.0 mL·min-1.The detection wavelength was 230 nm.The chromatography was conducted at 30℃.Restults The linear range of atorvastatin was 0.03-0.4 mg·mL-1(r=1).The average recovery was 99.9% and the RSD was 0.05%.Conclusion The method is simple,quick and accurate,which is suitable for the determination of aminomethylbenzoic acid and related substances in aminomethylbenzoic acid injection. |
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| Keywords: | aminomethylbenzoic acid injection HPLC content determination related substance |
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