邬方宁.高效液相色谱法测定米诺膦酸片中米诺膦酸[J].现代药物与临床,2011,26(1):66-67
高效液相色谱法测定米诺膦酸片中米诺膦酸
Determination of minodronic acid in Minodronic Acid Tablets by HPLC
  
DOI:10.7501/j.issn.1674-5515.[year].[issue].[sequence]
中文关键词:  米诺膦酸片  米诺膦酸  骨质疏松  离子对  高效液相色谱法
英文关键词:Minodronic Acid Tablets  minodronic acid  osteoporosis  ion pair  HPLC
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邬方宁 天津市药品审评中心天津 300191 
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中文摘要:
      摘 要:目的 建立高效液相色谱法测定米诺膦酸片中米诺膦酸。方法 采用安捷伦XDB-C18色谱柱(250 mm×4.6 mm,5 μm),流动相为0.03 mol/L焦磷酸钠水溶液(含四丁基溴化铵0.322 g/L,以磷酸调节pH 7.5)-甲醇(85∶20),体积流量1 mL/min,柱温30 ℃,检测波长280 nm,进样量20 μL。结果 米诺膦酸在0.02~0.18 mg/mL时,峰面积与质量浓度呈良好的线性关系(r=0.999 9)。结论 该方法准确、可靠,可作为米诺膦酸片的测定方法。
英文摘要:
      Abstract: Objective To establish a RP-HPLC method for the determination of minodronic acid in Minodronic Acid Tablets. Method The Agilent column XDB-C18 (250 mm×4.6 mm, 5 μm) was used. The mobile phase consisited of 0.03 mol/L sodium pyrophosphate (0.322 g/L tetrabutylammonium bromide, adjusting pH value to 7.5 with phosphorous acid)-methanol (85∶20). The flow rate was 1.0 mL/min with the column temperature at 30 ℃. The detection wavelenth was 280 nm and the injection volumn was 20 μL. Results The solution of minodronic acid was stability. The linear range for minodronic acid was 0.02—0.18 mg/mL (r=0.999 9). Conclusion The method is accurate and reliable, which is suitable for the determination of Minodronic Acid Tablets.
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