论文部分内容阅读
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 establish an inhibitory ion chromatography method for the determination of sodium phosphate, sodium chloride, antioxidant sodium thiosulfate and related phosphates and phosphites in the antiviral drug foscarnet sodium chloride injection. Methods: IonPac AS11-HC anion column (250 mm × 4 mm) was used. The mobile phase A was consisted of 0.1 mol·L-1 sodium hydroxide solution and the mobile phase B was eluted with a gradient of 1.0 mL · min -1 with ASRS 300 4 mm self-Regenerating Suppressor suppressor to suppress current 124 mA and detector to conduct conductivity detector. Results: The components were well separated. The linear ranges of foscarnet and chloride were 0.0012-1.2 mg · mL-1 (r = 0.9995) and 0.546-546 μg · mL-1 (r = 0.9995) respectively. The recoveries were 99.1% and 100.8% The linear range of sodium was 1 ~ 100μg · mL-1 (r = 0.9996) and the recovery rate was 101.4%. The linear range of the known phosphate and phosphite was 0.39-39μg · mL-1 (r = 0.9993) The detection limits (S / N = 3) were 0.20μg · mL-1 and 0.23μg · mL-1, respectively. Conclusion: The method is validated by the method and can be used for the quality control of sodium foscarnet sodium chloride injection.