反相高效液相色谱法考察注射用头孢米诺钠的稳定性  

Content Determination and Stability of Cefminox Sodium for Injection by RP- HPLC

作　　者：彭贵琴 陈万一[1] 廖斌[1] 

机构地区：[1]重庆市肿瘤研究所,重庆400030

出　　处：《中国药业》2014年第1期27-28,共2页China Pharmaceuticals

摘　　要：目的建立测定注射用头孢米诺钠含量的反相高效液相色谱法，考察其常规试验条件下的稳定性。方法色谱柱为DiamosilC18柱（150mm×4．6mm，5p．m），流动相为醋酸-甲醇-四氢呋喃（99：0．5：0．5），流速为1．0mL／min，检测波长为254nm，柱温为40℃。结果注射用头孢米诺钠的质量浓度在10～100μg／mL范围内与峰面积线性关系良好（r=0．9999）。平均回收率为99．30％，日内、日间精密度RSD均小于1％（n=5），重复性良好。对照品头孢米诺5d内稳定；头孢米诺钠的0．9％氯化钠注射液溶液在4℃下避光放置3d，样品含量大于95．00％，稳定性较好。结论该方法简洁，准确，重现性好，为试验动物的准确用药及药代动力学研究提供了理论依据。Objective To establish a reversed phase high performance liquid chromatography（RP- HPLC） method for detecting the content of Cefminox Sodium for Injection and to investigate its stability under the routine test conditions. Methods Cefminox Sodium for Injection was dissolved by the physiological saline, diluted by the mobile phase and detected by RP- HPLC, in which the chromato- graphic column was Diamosil Cls column（150 mm x 4. 6 ram,5 Ixm）, the mobile phase was acetic acid- methyl alcohol- tetrahydrofuran （99：0.5：0.5）, the flow velocity was 1.0mL/min, the detecting wavelength was 254 nm and the column temperature was 40~C. Results The detecting concentration of Cefminox Sodium for Injection within the range of 10- 100 ~g/mL had the good linear rela- tion（ r=0. 999 9）. The average recovery rate was 99.30%, both of the intra-day and inter-day RSD were less than 1% （n=5）, the repeatability was good. The reference substance cefminox was stable within 5 d; the 0. 9% psychological saline solution of Cefminox Sodium For Injection was darkly preserved under 4 ~C for 3 d , its sample content would be over 95.00% with good stability. Conclusion This method is simple and accurate with good repeatability, which offers the theoretical basis for the accurate medication of the experi- mental animals and the pharmacokinetic study.

关 键 词：反相高效液相色谱法 头孢米诺钠 稳定性 

分 类 号：R927.11[医药卫生—药学] R978.11