| 注射用头孢唑肟钠中有关物质的HPLC法测定 |
| |
| 引用本文： | 郭艳娟,杨倩,曹晓云. 注射用头孢唑肟钠中有关物质的HPLC法测定[J]. 国外医药(植物药分册), 2014, 0(8): 872-875 |
| |
| 作者姓名： | 郭艳娟 杨倩 曹晓云 |
| |
| 作者单位： | 天津市药品检验所,天津,300070 |
| |
| 摘 要： | 目的建立测定注射用头孢唑肟钠中有关物质的HPLC法。方法采用AgientEclipseC18色谱柱（250mm×4．6mm，5μm）：以乙腈-pH3．6缓冲液（取枸橼酸1．42g、磷酸氢二钠2．31g，加水溶解并稀释至1000mL）为流动相，进行梯度洗脱；检测波长：254nm；柱温：40℃；体积流量：0．8mL／min；进样量20μL。结果头孢唑肟在0．24-14．52μg／mL与峰面积呈良好的线性关系（r=1．0000），最低检出质量浓度0．03μg／mL。结论采用的HPLC方法简单、专属性强，可有效控制注射用头孢唑肟钠产品的质量。
|
| 关 键 词： | 注射用头孢唑肟钠 有关物质 高效液相色谱 |
Determination of related substances in Ceftizoxime Sodium for injection by HPLC |
| |
| GUO Yan-juan , YANG Qian , CAO Xiao-yun. Determination of related substances in Ceftizoxime Sodium for injection by HPLC[J]. , 2014, 0(8): 872-875 |
| |
| Authors: | GUO Yan-juan YANG Qian CAO Xiao-yun |
| |
| Affiliation: | ( Tianjin Institute for Drug Control, Tianjin300070, China) |
| |
| Abstract: | Objective To establish a method for the determination of related substances in Ceftizoxime Sodium for injection by HPLC. Methods The determination was carried out on Agient Eclipse C18 column （250 mm × 4.6mm, 5 μm） with the mobile phase containing acetonitrile-buffer solution （pH 3.6） （dissolve citric acid monohydrate 1.42 g and disodium hydrogen phosphate dodecahydrate 2.31 g in water and diluted to 1 000 mL） with gradient elution. The detective wavelength was set at 254 nm. The temperature of column was set 40 ℃. The flow rate was 0.8 mL/min with injection volume of 20μL. Results The linearity range of ceftizoxime sodium was 0.24 -- 14.52 μg/mL （r=l.000 0）, and LOD was 0.03 μg/mL. Conclusion The method is simple and selective to be used for the quality control of Ceftizoxime Sodium for injection products effectively. |
| |
| Keywords: | Ceftizoxime Sodium for injection related substance HPLC |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ |
