高效液相色谱测定葡萄糖酸钙片含量和溶出度的方法研究  

Content and dissolution determination of Calcium Gluconate Tablets by HPLC

作　　者：邓映明 张雁 曾玉梅 刘志辉 DENG Yingming;ZHANG Yan;ZENG Yumei;LIU Zhihui(Chemical Room,Meizhou Institute for Food and Drug Control,Meizhou,Guangdong 514071,China)

机构地区：[1]梅州市食品药品监督检验所化学室,广东梅州514071

出　　处：《医药前沿》2022年第27期6-8,12,共4页Journal of Frontiers of Medicine

摘　　要：目的:建立高效液相色谱测定葡萄糖酸钙片的含量和溶出度的方法。方法:采用色谱柱为安捷伦ZORBAXSBAq(250 mm×4.6 mm,5μm),流动相为0.05 mol·L^(-1)磷酸二氢钾溶液,磷酸调节pH至2.8,流速0.5 mL·min^(-1),检测波长210nm,柱温30℃,进样量10μL。采用浆法测定葡萄糖酸钙的溶出度,结果:葡萄糖酸钙在0.1103~2.207 mg·mL^(-1)范围内线性关系良好(r=0.9996),平均回收率为100.54%(RSD=0.74%,n=9),检测限为3.8 ng。样品在45 min的累积溶出量均大于90%。结论:本方法操作简单、准确性与专属性好,可用于测定葡萄糖酸钙片的含量和溶出度。Objective To establish an HPLC method for content and dissolution determination of Calcium Gluconate Tables.Methods Agilent ZORBAX SB-Aq column(250 mm×4.6 mm,5μm)was adopted for the HPLC analysis,the mobile phase was 0.05 mol·L^(-1) KH2PO4(pH=2.8)with a flow rate at 0.5 mL·min^(-1);The detection wavelength was 210 nm,the column temperature at 30℃,Injection volume was 10μL.Slurry method was used to determine the dissolution of Calcium Gluconate.Results The linear rang of Calcium Gluconate was 0.1103~2.207 mg·mL^(-1)(r=0.9996),The average recovery rate was 100.54%(RSD=0.74%,n=9).The detection limit was 3.8 ng.The dissolution of samples in 45 min was higher than 90%.Conclusion The method is simple,rapid,accurate and suitable for content and dissolution determination of Calcium Gluconate Tables.

关 键 词：高效液相色谱法 葡萄糖酸钙片 含量 溶出度 

分 类 号：R917[医药卫生—药物分析学]