今日药学

2019, v.29(02) 90-92+96

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HPLC-ELSD法测定复合葡萄糖酸钠铁/蔗糖注射液中葡萄糖酸含量
Determination of Gluconic Acid Assay in Sodium Ferric Gluconate Complex in Sucrose Injection by HPLC-ELSD

陈树;刘留成;
CHEN Shu;LIU Liucheng;Jiangsu Province Hospital of TCM;Jiangsu Aosaikang Pharmaceutical Co.Ltd.;

摘要(Abstract):

目的建立高效液相色谱-蒸发光散射检测(HPLC-ELSD)法测定复合葡萄糖酸钠铁/蔗糖注射液中葡萄糖酸含量,以更好地控制高分子胶体注射剂的结构。方法色谱柱:Waters X-Bridge Amide(250 mm×4.6 mm,3.5μm);流动相:30 mmol·L~(-1)乙酸铵-乙腈=20∶80(V/V);流速:0.80 m L·min~(-1);柱温:30℃;蒸发光散射检测器:漂移管温度:105℃;氮气流速:2.5 L·min~(-1)。结果葡萄糖酸在89.99~539.9μg·m L~(-1)浓度范围内呈良好的线性关系,精密度、重复性、稳定性及回收率良好。结论建立的HPLC-ELSD法测定葡萄糖酸的方法稳定、可靠,适用于复合葡萄糖酸钠铁/蔗糖注射液中葡萄糖酸的质量控制。
OBJECTIVE To establish the HPLC-ELSD method for the determination of gluconic acid assay in sodium ferric gluconate complex in sucrose injection,so as to control the structure of polymer colloid. METHODS The chromatographic column:Waters X-Bridge Amide( 250 mm× 4.6 mm,3.5 μm),mobile phase: 30 mmol·L~(-1) ammonium acetate-acetonitrile = 20 ∶ 80( V/V),flow rate: 0.80 mL·min~(-1),column temperature: 30 ℃,ELSD drift tube temperature: 105 ℃,N_2 flow rate: 2. 5 L·min~(-1). RESULTS The gluconic acid content showed a good linear relationship in the range of 89.99-539.9 μg·m L~(-1). The precision,repeatability,stability and recovery were good. CONCLUSION The established HPLC-ELSD method is stable and controllable for the determination of gluconic acid. It can be used for the quality control of gluconic acid assay in sodium ferric gluconate complex in sucrose injection.

关键词(KeyWords): 复合葡萄糖酸钠铁/蔗糖注射液;葡萄糖酸;含量测定;高效液相色谱-蒸发光散射检测法
sodium ferric gluconate complex in sucrose injection;gluconic acid assay;content determination;HPLC-ELSD

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作者(Author): 陈树;刘留成;
CHEN Shu;LIU Liucheng;Jiangsu Province Hospital of TCM;Jiangsu Aosaikang Pharmaceutical Co.Ltd.;

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