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作 者:李何杏 彭洁[1] 洪建文[1] Li He-xing;Peng Jie;Hong Jian-wen(Guangdong Institute for Drug Control,NMPA Key Laboratory for Rapid Testing Technology of Drug,Guangzhou 510663)
机构地区:[1]广东省药品检验所,国家药品监督管理局药品快速检验技术重点实验室,广州510663
出 处:《中国抗生素杂志》2022年第2期179-182,共4页Chinese Journal of Antibiotics
基 金:广东省省级科技计划项目(No.2018B020207008)。
摘 要:目的优化并建立可用于两种处方的注射用盐酸头孢替安中碳酸钠含量测定方法。方法原子吸收分光光度法(AAS),光源:钠空心阴极灯,原子化器:空气-乙炔火焰原子化器,波长:330.3 nm,电离抑制剂:氯化钾。结果该方法在9.882~98.820μg/m L(Na+)浓度范围内线性关系良好,相关系数r=0.9996;两种处方的重复性试验RSD分别为1.2%和2.1%,平均回收率分别为98.7%(RSD=0.5%)和98.3%(RSD=0.8%)。结论本方法准确、重复性好、操作简便,易于推广,可用于注射用盐酸头孢替安中碳酸钠的质量控制。Objective To optimize and establish a method for the determination of sodium carbonate in cefotiam hydrochloride for injection for two cultivations.Methods Atomic absorption spectrometry(AAS)was used.Sodium hollow cathode lamp was used as the light source,air-acetylene flam atomizer was used as the atomizer,the wavelength was at 330.3 nm,and potassium chloride was used as ionization inhibitor.Results The linear relationship of the method was good in the range of 9.882~98.820μg/mL(Na+),the regression coefficient was 0.9996;The RSD of repeatability test for two cultivations were 1.2%and 2.1%,and the average recoveries of sodium carbonate were 98.7%(RSD=0.5%)and 98.3%(RSD=0.8%).Conclusion The method is accurate,reproducible,simple to operate,and easy to popularize,and can be used for the quality control of sodium carbonate in cefotiam hydrochloride for injection.
分 类 号:R917[医药卫生—药物分析学]
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