摘要
目的建立反相高效液相色谱法测定葡萄糖酸钙锌口服溶液中葡萄糖酸根的含量。方法色谱柱为赛默飞Thermo Acclaim Mixed-Mode WAX-1柱(250 mm×4.6 mm,5μm);流动相A为0.025 mol·L^(-1)磷酸二氢钾溶液(用三乙胺调节pH至6.0);流动相B为乙腈,梯度洗脱;流速为0.6 mL·min^(-1);柱温为35℃;检测波长为210 nm;进样体积为10μL。结果空白溶液、空白溶剂均不干扰葡萄糖酸根的测定,葡萄糖酸根在0.0545~0.5448 mg·mL^(-1)(r=1.000)内与峰面积线性关系良好,平均回收率在99.39%~101.2%,RSD<2.0%。结论本法灵敏度高,专属性强,可准确测定葡萄糖酸钙锌口服溶液中葡萄糖酸根的含量。
Objective To establish an RP-HPLC method to determine gluconate acid radical in calcium gluconate oral solution.Methods The chromatographic column was Thermo Acclaim Mixed-Mode WAX-1(250 mm×4.6 mm,5μm).Mobile phase A was a monopotassium phosphate solution of 0.025 mol·L^(-1)(adjusting pH to 6.0 by triethylamine).Mobile phase B was acetonitrile,with gradient elution.The flow rate was 0.6 mL·min^(-1).The detection wavelength was 210 nm.The column temperature was set at 35℃and the injection volume was 10μL.Results The negative blank solution and the blank solvent had better separation of the gluconate.The calibration curve of gluconate acid radical had a good linearity at 0.0545~0.5448 mg·mL^(-1)(r=1.000).The average recoveries ranged at 99.39%~101.2%,with RSDs all less than 2.0%.Conclusion The method is sensitive and accurate,which is suitable for the determination of gluconate acid radical in calcium gluconate oral solution.
作者
刘伟
毛柯
秦绍刚
汪梦美
夏宇航
张蒙蒙
陶俊钰
刘为中
LIU Wei;MAO Ke;QIN Shao-gang;WANG Meng-mei;XIA Yu-hang;ZHANG Meng-meng;TAO Jun-yu;LIU Wei-zhong(Hefei Industrial Pharmaceutical Institute Co.,Ltd.,Hefei 230601;Hefei Food and Drug Inspection Certer,Hefei 238000)
出处
《中南药学》
2023年第8期2174-2177,共4页
Central South Pharmacy
作者简介
刘伟,男,硕士研究生,主要从事药品研发与质量研究,email:32287671@qq.com;通信作者:陶俊钰,女,主任药师,主要从事药品检验与质量研究,email:942884082@qq.com。
