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目的建立用HPLC测定注射用亚锡依替菲宁(EHIDA药盒)含量的方法。方法采用Waters C18(4.6mm×150mm,5μm)的色谱柱,以甲醇-水-磷酸(55∶45∶0.075)为流动相,检测波长为220nm,流速1.0mL·min-1。结果依替菲宁在32～384μg·mL-1内成线性关系,Y=1789041X+91432(r=0.99992)平均回收率为98.77%,RSD为0.43%。结论本方法操作简便,结果准确,可用于EHIDA药盒含量的快速定量分析。
OBJECTIVE To establish a method for the determination of etidronate (EHIDA kit) for injection by HPLC. Methods A Waters C18 (4.6 mm × 150 mm, 5 μm) column was used with a mobile phase of methanol-water-phosphoric acid (55:45:0.075). The detection wavelength was 220 nm and the flow rate was 1.0 mL · min-1. Results The effeining had a linear relationship within 32 ~ 384μg · mL-1. The average recovery of Y = 1789041X + 91432 (r = 0.99992) was 98.77% and the RSD was 0.43%. Conclusion The method is simple, accurate and can be used for rapid quantitative analysis of EHIDA kit.