HPLC法测定帕米膦酸二钠注射液的含量

目的建立离子交换高效液相色谱法测定帕米膦酸二钠的方法。方法采用IC—Paktm Anion HR色谱柱，以2mmol·L^-1硝酸溶液（用5mol·L^-1硝酸溶液调节pH值至2．70）为流动相，检测波长230nm流速1．0m L·min^-1，进样量30止。结果帕米膦酸进样量在3．82—45．85ug范围内与峰面积呈良好的线性关系（r=0．9988，n=7），回收率为100．0％（RSD=1．08％，n=9）。结论建立方法操作简便，结果准确，可应用日常实验的检测。

Determination of content of pamidronate sodium by HPLC

Objective To establish an ion - exchange HPLC method for the determination of content of pamidronate disodium for injection. Methods The determination was performed on IC - Paktm Anion HR（ 150mm × 4.6mm） column with 2mmol· L^-1 nitric acid （adjust pH = 2.70 with 5mol· L^-1 nitric acid） as mobile phase at a flow rate of 1.0ml· L^-1 ,the sample size was 30ul and the detection wavelength was 230nm. Results The linear range of pamidronate was 3.82 - 45. 85ug（r=0.9988,n=7）. the mean recovery rate was 100.0% （RSD = 1.08% ,n =9）. Conclusion The methed is convenient, accurate and suitable for the assay of pamidronate disodium injection.