HPLC法测定注射用头孢硫脒有关物质
发布时间：2018-10-30 21:10
【摘要】：目的建立适用于注射用头孢硫脒有关物质检查的HPLC法。方法采用_(1 8)色谱柱(Kromasil 100-5C_(1 8),250mm×4.6mm,5μm),以磷酸盐缓冲液(取无水磷酸氢二钠2.76g,柠檬酸1.29g,加水溶解并稀释成1000m L)-乙腈(86:14)为流动相;检测波长为254nm。结果自身对照溶液在1~108μg/m L范围内,溶液浓度和峰面积线性关系良好(r=0.9999),头孢硫脒最低检出限为2ng。结论本方法操作简便,专属性强,结果可靠,可用于注射用头孢硫脒有关物质的测定,已应用于中国药典2015年版注射用头孢硫脒质量标准。
[Abstract]:Objective to establish a HPLC method for the determination of cefathiamidine for injection. Methods Kromasil 100-5C18 column and 250mm 脳 4.6 mm ~ 5 渭 m), were used in phosphate buffer solution (2.76 g anhydrous disodium hydrogen phosphate, 1.29 g citric acid). The mobile phase was dissolved in water and diluted to 1000ml) -acetonitrile (86:14). The detection wavelength is 254 nm. Results the linear relationship between the concentration and the peak area of the autocontrol solution was good in the range of 1 ~ 108 渭 g / mL (r = 0.9999), and the minimum detection limit of cefathiamidine was 2 ng / mL. Conclusion the method is simple, specific and reliable. It can be used for the determination of cefathiamidine for injection. It has been applied to the quality standard of cefathiamidine for injection in Chinese Pharmacopoeia 2015.
【作者单位】： 广东省药品检验所;
【基金】：广东省医学科学技术研究基金(No.2015117103428214)
【分类号】：R927;O657.72
，
本文编号：2301194
[Abstract]:Objective to establish a HPLC method for the determination of cefathiamidine for injection. Methods Kromasil 100-5C18 column and 250mm 脳 4.6 mm ~ 5 渭 m), were used in phosphate buffer solution (2.76 g anhydrous disodium hydrogen phosphate, 1.29 g citric acid). The mobile phase was dissolved in water and diluted to 1000ml) -acetonitrile (86:14). The detection wavelength is 254 nm. Results the linear relationship between the concentration and the peak area of the autocontrol solution was good in the range of 1 ~ 108 渭 g / mL (r = 0.9999), and the minimum detection limit of cefathiamidine was 2 ng / mL. Conclusion the method is simple, specific and reliable. It can be used for the determination of cefathiamidine for injection. It has been applied to the quality standard of cefathiamidine for injection in Chinese Pharmacopoeia 2015.
【作者单位】： 广东省药品检验所;
【基金】：广东省医学科学技术研究基金(No.2015117103428214)
【分类号】：R927;O657.72
，
本文编号：2301194
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