头孢地尼有关物质分析方法的比较研究.pdfVIP

. 610 . 1001-8689(2012)08-0610-05 * ( 100050) 201034 201034 ChP2010USP34 R917 A Comparison of analytical methods for cefdinir related substances Li Jin, Wang Li-xin, Zhang Dou-sheng and Hu Chang-qin (National Institutes for Food and Drug Control, Beijing 100050) Abstract Objective To compare and optimize the analytical method for cefdinir related substance in Chinese Pharmacopoeia 2010 edition and United States Pharmacopoeia 34 edition. Methods Cefdinir and its related substances were analyzed using methods in two Pharmacopoeia; an evaluation was made between the two methods by application of the theoretical plate number and resolution parameters; two dimensional chromatographic correlation spectroscopy technique was applied to identify cefdinir related substances detected in two different methods; analytical method was further optimized by adjusting the gradient elution system. Results The separation ability of method in ChP 2010 edition is superior to USP 34; chromatographic correlation spectroscopy technique showed that cefdinir related substances had the same retention behavior when analyzed by the two different methods; the degradation impurity anti-cefdinir and synthesis intermediate acetyl cefdinir was effectively separated by the optimized method. Conclusion The separation capability of optimized method is superior to ChP2010 edition and USP34, which is su