反相高效液相色谱法测定帕米膦酸二钠的含量

Content Determination of Pamidronate Disodium by RP-HPLC

目的：建立以反相高效液相色谱法测定帕米膦酸二钠含量的方法。方法：色谱柱为C18，流动相为乙腈-0．4％乙二胺四醋酸二钠的氢氧化钠溶液（14：86），流速为0．6mL·min^-1，进样量为10μL；荧光检测器检测，激发光波长为395nm，发射光波长为480nm。结果：帕米膦酸二钠检测浓度在7．2～16．8μg·mL^-1范围内呈良好的线性关系（r=0．9998，n=9），回收率为100．11％（RSD=0．7％，n=9）。结论：该方法操作简便，结果准确。

OBJECTIVE： To establish a RP -HPLC method for the determination of pamidronate disodium. METHODS： The determination was performed on C18 column with acetonitrile - 0.4% sodium hydroxide solution of EDTA- Na2 （14 ： 86） as mobile phase at a flow rate of 0.6mL · min^-1, the sample size was 10μL and the detection was performed by fluorescence detector with excitation wavelength at 395nm and emission wavelength at 480nm. RESULTS： The linear range of pamidronate disodium was 7.2-16.8μg · mL^-1（r = 0.999 8, n = 9）, the recovery rate was 100.11% （RSD = 0.7%, n = 9） . CONCLUSIONS： The established method is simple and accurate.