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HPLC法测定帕米膦酸二钠注射液的含量
引用本文:蔡玫,许晋星.HPLC法测定帕米膦酸二钠注射液的含量[J].中国热带医学,2008,8(9):1636-1637.
作者姓名:蔡玫  许晋星
作者单位:海南省药品检验所,海南,海口,570216
摘    要: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。

关 键 词:离子交换高效液相色谱  帕米膦酸二钠注射液  条件优化

Determination of content of pamidronate sodium by HPLC
CAI Mei,XU Jin-xing.Determination of content of pamidronate sodium by HPLC[J].China Tropical Medicine,2008,8(9):1636-1637.
Authors:CAI Mei  XU Jin-xing
Institution:CAI Mei, XU Jin - xing. ( Hainan Provincial Institute for Drug Control, Haikou 570216, Hainan, P. R. China)
Abstract: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.
Keywords:Ion - exchange HPLC  Pamidronate disodium injection  Assay
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