离子色谱法测定膦甲酸钠注射液含量及有关物质

Determination of Foscarnet Sodium Injection and Its Related Substance by Ion Chromatography

目的建立离子色谱法测定膦甲酸钠注射液含量和有关物质的测定方法。方法色谱柱为Dionex Ionpac AG18(4 mm×50 mm,13μm)+AS18(4 mm×250 mm,7.5μm),以在线EG发生罐产生KOH作为流动相,梯度洗脱,流速1 mL·min-1,电导检测,柱温30℃。结果膦甲酸钠线性范围2～100μg.mL-1,相关系数r=0.999 8,检出限0.3μg·mL-1,杂质亚磷酸根和磷酸根线性范围0.05～2μg·mL-1,相关系数分别为r=0.999 9和r=0.999 8。膦甲酸钠日内精密度RSD为0.35%(n=5),日间精密度0.41%(n=5)。平均加样回收率101%。结论本方法快速、灵敏,专属性强,适用于膦甲酸钠注射液含量及有关物质亚磷酸根和磷酸根的测定。

OBJECTIVE To establish a gradient ion chromatography method to determine the content of foscarnet sodium injection and its related substances. METHODS The separation was performed on an Ionpae AG18 （4 mm × 50 ram, 13 μm） ＋ ASia column （4. 0 mm × 250 mm ,7. 5 μm） using potassium hydroxide produced by eluent generator （EG） as the mobile phase at a flow rate of 1 mL · min^-1 Suppressed conductivity detection was adtopted. The column temperature was maintained at 30 ℃. RESULTS The calibration curve of foscarnet sodium was linear between 2 - 100 μg · mL^-1 r = 0. 999 8 ） , and the calibration curves of the related substances were linear between 0. 05 - 2 μg · mL^-1 （ r = 0. 999 9 and r = 0. 999 8 ）. The intra-day and inter-day RSDs of foscarnet sodium were 0. 35% （ n = 5 ） and 0. 41% （ n = 5 ） , respectively. The average recovery was 101%. CONCLUSION The method is specific, sensitive and can be applied to determine the content and impurities of foscarent sodium injection.