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目的:建立高效液相色谱法测定注射用福沙匹坦二甲葡胺中乙二胺四乙酸钙钠的含量。方法:采用Agilent Zorbax Eclipse XDB C18(250 mm×4.6 mm,5μm)色谱柱;以0.2%四丁基氢氧化铵溶液(用磷酸调节p H 4.0)-乙腈(85∶15)为流动相,流速为1.0 ml·min-1,检测波长为254 nm,柱温为35℃,进样量为20μl。结果:乙二胺四乙酸钙钠在26.06~104.24μg·ml-1(r=0.999 8)范围内呈现良好的线性关系;平均回收率为99.51%(RSD=0.25%,n=9)。结论:该方法简便、灵敏、准确、专属性强,重复性好,可作为注射用福沙匹坦二甲葡胺中乙二胺四乙酸钙钠含量测定的方法。
OBJECTIVE: To establish a HPLC method for the determination of calcium sodium edetate in amoxicillin for injection. Methods: The mobile phase consisted of an Agilent Zorbax Eclipse XDB C18 (250 mm × 4.6 mm, 5 μm) column with 0.2% tetrabutylammonium hydroxide (p H 4.0 adjusted with phosphoric acid) -acetonitrile (85:15) ml · min-1, the detection wavelength was 254 nm, the column temperature was 35 ℃ and the injection volume was 20μl. Results: The calcium sodium edetate showed good linearity in the range of 26.06-104.24μg · ml-1 (r = 0.999 8). The average recovery was 99.51% (RSD = 0.25%, n = 9). Conclusion: The method is simple, sensitive, accurate, specific and reproducible. It can be used as a method for the determination of sodium calcium edetate in foxifloxacin for injection.