| HPLC法测定比阿培南二聚物方法研究及其降解途径考察 |
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| 引用本文： | 刘俊华,张莉,程玉宝,赫涡涛. HPLC法测定比阿培南二聚物方法研究及其降解途径考察[J]. 药物分析杂志, 2012, 0(3): 468-472 |
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| 作者姓名： | 刘俊华 张莉 程玉宝 赫涡涛 |
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| 作者单位： | 珠海联邦制药股份有限公司 |
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| 基金项目： | 2009年粤港关键领域重点突破项目(项目编号:TC09B863-4) |
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| 摘 要： | 目的:建立了测定比阿培南二聚物的高效液相色谱法,同时考察二聚物的降解途径。方法:采用高效液相色谱法:色谱柱为C18柱,流动相为0.05%三氟乙酸溶液-乙腈(92∶8),检测波长为318 nm,流速为1.0 mL.min-1。结果:比阿培南溶液浓度在0.000 2～0.076 8 mg.mL-1范围内,溶液浓度与峰面积线性关系良好(r=1.000)。比阿培南二聚物A和二聚物B测定结果的重复性良好,RSD(n=6)分别为2.5%和0.8%。结论:本方法操作简便,结果可靠,可以用于比阿培南中二聚物的检测。
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| 关 键 词： | 1β-甲基碳青霉烯类抗生素 β-内酰胺类抗生素 抗菌作用 比阿培南 高分子杂质 聚合物 降解途径 |
HPLC determination of biapenem dimer and study on its degradation pathways |
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| LIU Jun-hua,ZHANG Li,CHENG Yu-bao,HE Wo-tao. HPLC determination of biapenem dimer and study on its degradation pathways[J]. Chinese Journal of Pharmaceutical Analysis, 2012, 0(3): 468-472 |
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| Authors: | LIU Jun-hua ZHANG Li CHENG Yu-bao HE Wo-tao |
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| Affiliation: | (Zhuhai United Laboratories Co.,Ltd.,Zhongshan 528467,China) |
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| Abstract: | Objective:To establish an HPLC analytical method for the determination of biapenem dimer,and study its degradation pathways.Methods:The analytical Column was C18,the mobile phase was 0.05% trifluloracetic acid solution-acetonitrile(92∶ 8),the detective wavelength was 318 nm,and the flow rate was 1.0 mL·min-1.Results:The biapenem had a good linearity in the range of 0.0002-0.0768 mg·mL-1(r=1.000).Repeatability of biapenem dimer A and dimer B was fine,with RSD(n=6)of 2.5% and 0.8%.Conclusion:The method is simple,rapid and reliable,it is applicable for the quality control of biapenem dimer. |
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| Keywords: | 1β-methylcarbapenem antibiotics β-lactam antibiotics antibacterial action biapenem high molecular mass impurity polymer degradation pathway |
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