反相高效液相色谱法考察注射用头孢硫脒与注射用卡络磺钠配伍稳定性

目的考察室温条件下头孢硫脒与卡络磺钠在0．9％氯化钠注射液中的配伍稳定性。方法采用反相高效液相色谱法分别测定配伍液中头孢硫脒与卡络磺钠0～6h内的含量变化，并观察配伍液的外观及pH值。结果头孢硫脒与卡络磺钠的检测波长分别为254、364nm；头孢硫脒与卡络磺钠的回归方程分别为Y硫=9335．3X硫-8315．1（r=0．9996，n=6）和Y卡=31133X卡＋7013．7（r=0．9995，n=6），头孢硫脒在25．0～250．0mg／L、卡络磺钠在8．2～82．0mg／L浓度范围内与峰面积呈良好的线性关系；精密度试验测得头孢硫脒和卡络磺钠峰面积相对标准偏差（RSD）分别为0．55％和0．63％；重复性试验测得头孢硫脒峰和卡络磺钠峰面积RSD分别为0．81％和0．90％（n=6）；稳定性试验测得头孢硫脒与卡络磺钠峰面积RSD分别为0．99％和0．76％（n=6）。6h内配伍液外观无明显变化、pH及含量均变化明显。结论在室温下、6h内，注射用头孢硫脒与注射用卡络磺钠不宜在0．9％氯化钠注射液中配伍使用。

Observation of stability of cefathiamidine for injection and carbazochrome sodium sulfonate for injection

Objective To study the stability of cefathiamidine for injection and carbazochrome sodium sulfonate for injection in 0.9% sodium chloride injection at ambient temperature （20 ± 1 ） ℃] , in order to provide a scientific basis for rational use of drug in clinical practice. Methods The changes of the contents of cefathiamidine and carbazochrome sodium sulfonate were determined respectively by reversed phase high performance liquid chromatography （ RP-HPLC ）. The changes of appearance and pH values were observed within 6 hours. Results The detection wavelengths were 254 nm and 364 nm for cefathiamidine and carbazochrome sodium sulfonate. The calibration equations were Ycef = 9335.3Xcof - 8315.1 （r = 0. 9996, n = 6） and Ycar = 31133Xcar ＋ 7013.7 （ r = 0. 9995, n = 6）. No significant change was demonstrated in the outward appearance. The obvious changes were noted in the pH values and contents for the mixed solution within 6 hours. Conclusion Cefathiamidine for injection cannot be mixed with carbazochrome sodium sulfonate for injection at ambient temperature （20 ± 1 ） ℃] within 6 hours.