摘要
目的：建立一种较易操作并可有效控制注射用头孢地嗪钠中有关物质的HPLC方法。方法：采用4种不同色谱条件的HPLC法研究3个厂家的注射用头孢地嗪钠的杂质谱。方法 1、2均为等度洗脱法,分别为日本药局方法和现行版《中国药典》法,方法3为梯度洗脱法,方法4系在方法2基础上改变检测波长建立的方法。结果：方法1~4分别能检测出3、4、9、4种杂质,4种方法检查的3个厂家的样品杂质谱一致;方法4较方法3易于操作,较方法1各杂质峰响应值明显大且灵敏,较方法2基线噪音小。结论：建立的方法4更简便、准确,适用于注射用头孢地嗪钠的有关物质检查。
OBJECTIVE： To establish an HPLC method easier to operate and more effective to control related substances in Ce- fodizime sodium for injection. METHODS ： HPLC under 4 kinds of chromatogram condition were adopted to study the impurity pro- files of Cefodizime sodium for injection from 3 manufactories . Methods 1 and 2 were isocratic elution methods from Japanese Phar- macopoeia and Chinese Pharmacopeia. Method 3 was gradient elution. The detection wavelength of method 4 was adjusted on the basis of method 2. RESULTS： 4 methods were able to identify 3, 4, 9 and 4 kinds of impurities, respectively. The impurity pro- files of samples from 3 manufactories by 4 methods were consistent. The method 4 was easier to operate than method 3; response values of its each impurity peak were obviously larger and more sensitive than method 1 ; its baseline noise was smaller than meth- od 2. CONCLUSIONS： The method 4 is simpler and more accurate than other 3 methods, and it is suitable for the impurity detec- tion of Cefodizime sodium for injection.
出处
《中国药房》
CAS
CSCD
2013年第37期3525-3527,共3页
China Pharmacy
关键词
高效液相色谱法
注射用头孢地嗪钠
杂质谱
有关物质
检查
HPLC
Cefodizime sodium for injection
Impurity profiles
Related substances
Determination
