注射用替卡西林钠克拉维酸钾(15∶1)中高聚物杂质的检测  

Determination of High Polymer Impurities in Ticarcillin Disodium and Potassium Clavulanate(15∶1) for Injection by HPLC

作　　者：李海珊[1] 李左阳 汪娟 周正凤 

机构地区：[1]广东省佛山市第一人民医院,广东佛山528000 [2]北京满格医药科技有限公司,北京100000

出　　处：《中国药业》2013年第19期54-55,共2页China Pharmaceuticals

摘　　要：目的建立检测注射用替卡西林钠克拉维酸钾中高聚物杂质的高效液相色谱法。方法以TSKG2000SWXL柱（300mm×7．8mm，7μm）为色谱枉，以pH为3．5的磷酸盐缓冲液【0．15mL／L的磷酸氢二钠溶液-0．15mL／L的磷酸二氢钠溶液（95：5），用磷酸调pH至3．5】为流动相，检测波长为230nm，柱温为常温。结果高聚物杂质与替卡西林、克拉维酸钾能很好分离；其线性回归方程为Y=25725X＋16292，r=0．9992，含量检测的线性范围为6．402～12．804μg／mL。平均回收率为99．60％，RSD为0．46％。结论该法灵敏、准确，重现性好，可用于注射用替卡西林克拉维酸钾的高聚物杂质检查。Objective To establish a high performance liquid chromatography（HPLC） method for the determination of high polymer impuri- ties in Ticarcillin Disodium and Potassium Clavulanate（15 ： 1） for Injection. Methods The HPLC method was performed on the TSK G2000 SWxL column（300 mm ×7.8 mm, 7 μm）, using phosphate buffer solution [0.15 mL/L disodium phosphate solution-0. 15 mL/L sodium dihydrogen phosphate solution（95 ： 5）, adjusting pH to 3.5 with phosphoric acid] as the mobile phase under the detection wavelength of 230 nm and normal temperature. Results The high polymer impurities were well separated from tieareillin disodium and potassium clavulanate; the linear equation of the high polymer impurites was Y= 25 725 X ＋ 16 292, r = 0. 999 2. The average recovery rate was 99.60%, RSD was 0.46%. Conclusion The method is sensitive and accurate with good reproducibility,it can be used for the detection of the high polymer impuritites in Ticareillin Disodium and Potassium Clavulanate for Injection.

关 键 词：克拉维酸钾 替卡西林钠 高聚物杂质 高效液相色谱法 

分 类 号：R927.1[医药卫生—药学] R978.11