离子色谱法同时测定膦甲酸钠氯化钠注射液主药及抗氧剂和有关物质

Simultaneous determination of main medicine,antioxidant and related substances in foscarnet sodium-sodium chloride injection by IC method

目的：建立抗病毒药膦甲酸钠氯化钠注射液中主成分膦甲酸钠、氯化物,抗氧剂硫代硫酸钠及有关物质磷酸盐和亚磷酸盐的抑制型离子色谱测定方法。方法：采用IonPac AS11-HC阴离子色谱柱（250 mm×4 mm）,以0.1 mol·L-1氢氧化钠溶液为流动相A,以水为流动相B,梯度洗脱,流速1.0 mL·min-1,采用ASRS 300 4 mm self-Regenerating Suppressor抑制器,抑制电流124 mA,检测器为电导检测器。结果：各组分分离度良好。膦甲酸钠和氯化物的线性范围分别为0.0012~1.2 mg·mL-1（r=0.9995）和0.546~546μg·mL-1（r=0.9995）,回收率分别为99.1%和100.8%;硫代硫酸钠线性范围为1~100μg·mL-1（r=0.9996）,回收率为101.4%;已知杂质磷酸盐和亚磷酸盐的线性范围分别为0.39~39μg·mL-1（r=0.9993）和0.34~34μg·mL-1（r=0.9994）,检测限（S/N=3）分别为0.20μg·mL-1和0.23μg·mL-1。结论：经方法学验证,本方法可用于膦甲酸钠氯化钠注射液的质量控制。

Objective： To approach an assay method for determination of main medicine foscarnet sodium,chloride,and antioxidant sodium thiosulfate,related substances phosphate and phosphite in foscarnet sodium- sodium chloride injection by ion chromatography（ IC）. Methods： An IC assay was developed. The assay was performed on an IonPac AS11- HC column（ 250 mm ×4 mm） with a gradient program using 0. 1 mol·L- 1sodium hydroxide solution- water as mobile phase.The flow rate was 1. 0 mL·min- 1. The suppressor was ASRS 300 4 mm self- Regenerating Suppressor. Suppress current：124 mA. The detector was electrolytic conductivity detector. Results： An excellent separation was achieved for all substances. The linear ranges of foscarnet sodium and chloride were 0. 0012- 1. 2 mg·mL- 1（ r =0.9995） and 0.546-546μg·mL- 1（ r =0.9995）,respectively. The average recoveries（ n =9） of foscarnet sodium and sodium chloride were99. 1% and 100. 8%,respectively. The linear range of sodium thiosulfate was 1-100 μg·mL- 1（ r =0.9996）,and the average recovery（ n = 9） was 101. 4%. The linear ranges of phosphate and phosphite were 0. 39- 39 μg·mL- 1（ r =0. 9993） and 0. 34-34 μg·mL- 1（ r =0.9994）,respectively.The detection limits of phosphate and phosphite（ S/N =3）were 0. 20 μg·mL- 1and 0. 23 μg·mL- 1,respectively.Conclusion：The method was proved to be rapid,accurate,and convenient,and provided a reliable way for evaluating the quality of foscarnet sodium- sodium chloride injection.