葡萄糖酸钙注射液含量测定质量标准提高的研究  

Improvements on the content determination of calcium gluconate injection for the quality standard

作　　者：戚龙献 陆爱玲 徐凡 刘任 QI Longxian;LU Ailing;XU Fan;LIU Ren(Jiangsu Chia Tia Fenghai Pharmaceutical Co.,Ltd.,Yancheng 222400,China)

机构地区：[1]江苏正大丰海制药有限公司,江苏盐城222400

出　　处：《中国药品标准》2022年第6期614-617,共4页Drug Standards of China

摘　　要：目的:建立全新的HPLC方法,同时测定葡萄糖酸钙注射液中葡萄糖酸钙、葡萄糖二酸钙的含量。方法:采用Shodex sugar色谱柱(8.0 mm×300 mm,5μm),以纯水(pH=3.0)为流动相,流速0.8 mL·min^(-1),柱温为35℃;示差折光检测器,检测器温度为40℃,外标法定量。结果:葡萄糖酸钙(1.2~2.8 mg·mL^(-1))、葡萄糖二酸钙(60~140μg·mL^(-1)),葡萄糖酸钙与葡萄糖二酸钙浓度与峰面积呈良好的线性关系;葡萄糖酸钙和葡萄糖二酸钙的平均回收率分别为98.9%和98.9%,RSD分别为0.30%和0.69%。测定样品两批,葡萄糖酸钙含量分别为102.5%、99.5%,葡萄糖二酸钙含量分别为103.2%、100.4%。结论:本法可同时测定葡萄糖酸钙与葡萄糖二酸钙的含量。Objective:To establish an HPLC method for the simultaneous determination of calcium gluconate and calcium saccharate in calcium gluconate injection.Methods:The test was performed on a Shodex sugar chromatographic column(8.0 mm×300 mm,5μm)under the isocratic elution of pure water(pH3.0).The flow rate was 0.8 mL·min^(-1),and the column temperature was 35℃.The differential refractive index detector was employed and the detection temperature was 40℃.External standard method was used for the quantification.Results:The concentrations of both calcium gluconate and calcium saccharate had a good linear relationship with their peak areas and the linear ranges of two analytes fell into 1.2-2.8 mg·mL^(-1) and 60-140μg·mL^(-1),respectively.The average recoveries of calcium gluconate and calcium gluconate were 98.9%and 98.9%with RSD values of 0.30%and 0.69%,respectively.The test results of two batches of samples showed that the contents of calcium gluconate fell into 102.5%and 99.5%,and those of calcium saccharate fell into 103.2%and 100.4%,respectively.Conclusion:The established method can be applied to the simultaneous quantification of calcium gluconate and calcium saccharate.

关 键 词：葡萄糖酸钙注射液 高效液相色谱法 葡萄糖酸钙 葡萄糖二酸钙 

分 类 号：R921.2[医药卫生—药学]