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目的:建立氯甲酸-9-芴甲酯(FMOC-Cl)柱前衍生化HPLC法测定注射用帕米膦酸二钠的含量。方法:碱性条件下供试品与FMOC-Cl进行衍生化反应,采用Hypersil ODS2(4.6 mm×250 mm,5μm)色谱柱,流动相为乙腈-0.4%EDTA溶液(用1 mol·L-1氢氧化钠溶液调节pH至7.2)(25∶75),流速1 mL·min-1,检测波长为265 nm。结果:帕米膦酸二钠浓度在0.05～1.00 mg·mL-1范围内与峰面积呈良好关系(r=0.9998),平均回收率为101.0%(n=9)。结论:该方法专属性好,适合用于注射用帕米膦酸二钠的含量测定。
OBJECTIVE: To establish a precolumn derivatization HPLC method for the determination of pamidronate disodium in injection by using FMOC-Cl. Methods: The derivatization reaction of FMOC-Cl with Hypersil ODS2 (4.6 mm × 250 mm, 5 μm) was carried out under alkaline conditions. The mobile phase consisted of acetonitrile-0.4% EDTA (1 mol·L-1 Sodium hydroxide solution to adjust the pH to 7.2) (25:75), the flow rate of 1 mL · min-1, detection wavelength of 265 nm. Results: The concentration of pamidronate in the range of 0.05-1.00 mg · mL-1 showed a good correlation with the peak area (r = 0.9998) and the average recovery was 101.0% (n = 9). Conclusion: The method is specific and suitable for the determination of pamidronate disodium for injection.