注射用利福霉素钠含量测定及配伍稳定性若干指标考察

Rifamycin sodium for injection determination and compatibility study of the stability of a number of indicators

目的建立高效液相色谱法测定注射用利福霉素钠的含量方法,考察输液配伍稳定性的若干指标。方法采用高效液相色谱法,色谱柱为Agilent Extended C18(250 mm×4.6 mm),流动相为甲醇-乙腈-0.075 mol·L-1磷酸二氢钾溶液-1.0 mol·L-1枸橼酸溶液(30∶30∶36∶4),流速为1.0 ml·min-1,检测波长为227 nm。按说明书要求进行注射用利福霉素钠与5%葡萄糖注射液、0.9%氯化钠注射液的配伍稳定性研究。结果利福霉素钠含量在0.041 9～0.293 4 g·L-1的浓度范围内,本法的线性良好,线性回归方程为A=3.36×107 C-3.11×104(n=7,R=0.999 90);平均回收率为100.46%。结论本法准确、灵敏、可靠;注射用利福霉素钠与5%葡萄糖注射液、0.9%氯化钠注射液配伍后,被观察的几项指标未见异常,建议在5 h内输液完毕。

Aim To establish an HPLC method for compatibility study of the stability of a number of indicators of rifamycin sodium.Methods High performance liquid chromatogra was used,column Agilent Extended C18（250 mm×4.6 mm）,and a mobile phase of methanol-acetonitrile-0.075 mol·L-1 potassium dihydrogen phosphate solution-1.0 mol·L-1 citrate solution（30∶30∶36∶4）.The flow rate was 1.0 ml·min-1,and detection wavelength at 227nm.According to prescribing information,rifamycin sodium for injection was compatible with 5% glucose injection,0.9% sodium chloride injection.Results The sodium content of rifamycin ranging from 0.041 9 to 0.293 4 mg·L-1 achieued a good linear relationship,A=3.36×107 C-3.11×104（n=7,R=0.999 90）.The average recovery was 100.46%.Conclusion This method is accurate,sensitive,and reliable.Rifamycin sodium for injection can be compatible with 5% glu-cose injection,0.9% sodium chloride injection,and several indicators were not abnormal.Infusion is recommended to complete in 5 hours.