摘要
目的:建立奥硝唑有关物质质控分析方法。方法:采用HPLC、TLC 2种方法进行检查。HPLC法以ODS色谱柱(250 mm×4.6 min,5μm),流动相为甲醇-水-冰醋酸(30:70:0.1),柱温为室温,流速为1.0 mL·min-1,检测波长为317 nm;TLC法采用硅胶GF254薄层板,展开剂为氯仿-冰醋酸-甲醇(85:10:5),置ZF-I型紫外分析仪254nm下检视。结果:在HPLC、TLC选定的色谱条件下,奥硝唑与其中间体及降解产物均能得到较好的分离。HPLC法最低检出浓度为50 ng·mL-1,最低检出量为1 ng;TLC法最低检出浓度为0.05 mg·mL-1,且分离度良好。结论:TLC方法快速、简便、重现性好,可用于奥硝唑有关物质的检查。
Objective:To study the method for the determination of the related substance of ornidazole. Methods: HPLC and TLC Methods were used. For HPLC,a ODS column(250 mm×4. 6 mm,5μm) was used. The mobile phase was methanol - water - acetic acid(30:70=0. l).The flow rate was 1.0 mL·min-1 and the detective wavelength was 317 nm;For TLC,silica gel GF254 thin layer plate was used. The developing solvent:chloroform - acetic acid -methanol(85:10:5). Result:Good separations of related substance for ornidazole could be achieved under the above systems. Conclusion: The TLC method is very simple, rapid and accurate. Furthermore, the method gives good separation of ornidazole and its related substances. It is proposed as an excellent method for the analysis of ornidazole and its related substances.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2004年第3期267-270,共4页
Chinese Journal of Pharmaceutical Analysis
