摘要
目的控制头孢曲松钠中三嗪环的残留量,减少过敏反应的发生,促进工艺改进。方法作者采用MS、IR与NMR等波谱技术对制备的三嗪环(triazin)样品进行结构确认,用HPLC法对其进行纯度测定;根据欧洲药典方法,用质量分数为1.0%的头孢曲松钠对照液做对照,以头孢曲松钠供试液中三嗪环的峰面积与质量分数为1.0%的对照液中头孢曲松钠的峰面积比来计算三嗪环的含量。结果制备三嗪环样品的工艺能够获得目标产物,质量分数纯度为99.72%;三嗪环与头孢曲松的相对保留时间为0.59,其含量质量分数为0.099%。结论该方法适合头孢曲松钠中残留的三嗪环的定性定量分析,其含量在安全限度范围内(质量分数不超过1.0%),患者可以放心使用。
Objective To decrease anaphylaxis of ceftriaxone sodium, and accelerate the process innovation through controlling residual triazin in ceftriaxone sodium. Methods The self-prepared triazin was identified through MS, IR and NMR method, and its quantitative assay was performed through HPLC method. The content of triazin in ceftriaxone sodium was calculated through peak area ratio between its area in test solution and ceftriaxone sodium area in 1.0 % reference solution according to European Pharmacopoeia. Results The target compound triazin was synthesized with the purity of 99.72 %. The relative retention time was 0.59, and its content was 0. 091%. Conclusions The method is suitable for the qualitative and quantitative analysis of the residual triazin in ceftriaxone sodium, and its content complies with security specification （not more than 1.0 % ）.
出处
《沈阳药科大学学报》
CAS
CSCD
北大核心
2007年第5期295-297,302,共4页
Journal of Shenyang Pharmaceutical University
