rp-hplc法测定注射用头孢美唑钠的含量.docVIP

RP-HPLC法测定注射用头孢美唑钠的含量 边原* 何林 夏祺悦（四川省人民医院·四川省医学科学院 药剂科，四川成都 610072） 中国分类号 文献标识码 文章编号 摘 要 目的：建立以反相高效液相色谱法测定注射用头孢美唑钠含量的方法。考察其日常实验条件下的稳定性。方法：采用生理盐水溶解，流动相进行稀释。以反相高效色谱法测定，其中色谱柱为C18，流动相为磷酸二氢铵水溶液-甲醇-四氢呋喃-10%四丁基氢氧化铵（700:280:25:12.8 V/V/V/V），流速为1.0 mL·min-1,检测波长为272 nm，柱温为30 ℃。结果：注射用头孢美唑钠的检测浓度在10—100 ug·mL-1范围内线性关系良好（r＝0.9999）。平均方法回收率为99.20%，日内、日间RSD均＜1％（n＝5），重复性良好。对照品头孢美唑5天内稳定；头孢美唑钠的生理盐水溶液4 ℃下避光放置5d，样品含量95%，稳定性较好。结论：本法简便、准确、重现性好，为实验动物的准确用药及药动学研究提供了理论依据。 关键词 反相高效液相色谱法；头孢美唑钠；稳定性 Detection of The Content Of Cefmetazole Sodium For Injection By RP-HPLC Yuan* Bian Qiyue Xia (People’s Hospital Of Sichuan Province Department of Pharmacy, Academy of Medical Science of Sichuan Province, Chengdu, Sichuan 610072，China) ABSTRACT OBJECTIVE: establish a method of detecting the content of the Cefmetazole Sodium for injection by RP-HPLC. Examine its stability under the daily examination conditions. METHODS: it was dissolved by the physiological saline, diluted by the mobile phase, and detected by RP-HPLC, of which the chromatographic column was C18, the mobile phase was ammonium dihydrogen phosphate water - methyl alcohol - tetrahydrofurfuryl carbinol-10% of Tetrabutylammonium hydroxide (700:280:25:12.8 V/V/V/V), the flow velocity was 1.0 ml·min-1, the detecting wavelength was 227nm and the column temperature was 30℃. RESULT: The linear relation of the detecting concentration of the Cefmetazole Sodium for injection within10-100 ug·mL-1 was well（r＝0.9999）. The average recovery rate was 99.20%, both of the intra-day and inter-day RSD were less than 1% (n = 5), the repeatability was good. Compared with the Cefmetazole, it was stable within 5 days. If the psychological saline water of Cefmetazole Sodium For Injection was darkly preserved under 4 ℃ for 5d , the sample content of it would be over 95% with good stability. CONCLUSION: This method is simple, accurate, with good repeatability, which offers the theory basis for the experiments of the accurat