HPLC法测定利福霉素钠及注射用利福霉素钠有关物质

Determination of related substances of rifamycin sodium and rifamycin sodium for injection by HPLC

目的建立HPLC梯度洗脱法测定利福霉素钠及注射用利福霉素钠的有关物质。方法选用Waters C18色谱柱,以0.18%磷酸二氢钠溶液(用8.5%的氢氧化钠溶液调解pH值至7.5)-乙腈(90:10)为流动相A;0.18%磷酸二氢钠溶液(用8.5%的氢氧化钠溶液调解pH值至7.5)-乙腈(50:50)为流动相B;梯度洗脱[0min(70%A)→35min(15%A)→37min(70%A)→47min(70%A)];流速为1mL/min,检测波长为254nm。结果经过方法学验证试验,认定方法可行。结论本方法灵敏、准确,专属性强。

Objective To establish an HPLC gradient elution method for determination of related substances in rifamycin sodium and rifamycin sodium for injection.Methods Waters C18 column was used as stationary phase.0.18% solution of sodium dehydrogenate phosphate （adjusted to pH 7.5 with 8.5% sodium hydroxide solution） -acetonitrile（90：10） was used as mobile phase A and 0.18% solution of sodium dehydrogenate phosphate （adjusted to pH 7.5 with 8.5% sodium hydroxide solution）-acetonitrile（50：50） as mobile phase B.Gradient elution method[0min （70%A）→35min （15%A）-→37min（70%A）→47min（70%A）] was used at the flow rate of 1 mL/min and the detection wavelength was 254nm.Results After the methodology verifying test,the method was proved to be feasible.Conclusion The method is sensitibe,accurate and specific.