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
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摘要
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.
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.
引文
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[2]王方海,赵维,陈建芳,等.补铁剂研究进展[J].药学进展,2016,40(9):680-688.
[3] Qunibi W Y. The efficacy and safety of current intravenous iron preparations for the management of iron-defi ciency anaemia a review[J].Arzneim Forsch,2010,60(6):399-412.
[4]金雪锋,刘留成,宗在伟,等.铁-糖复合物注射剂相似性评价研究进展[J].中国新药杂志,2018,27(7):797-802.
[5]Koskenkor V A,Frank T S,Weiss G,et al. The complex interplay of iron metabolism,reactive oxygen species,and reactive nitrogen species:insights into the potential of various iron therapies to induce oxidative and nitrosative stress[J]. Free Radic Biol Med,2013,65(6):1174-1194.
[6]Van W D B,Cavallo G,Spinowitz B S,et al. Safety and efficacy of iron sucrose in patients sensitive to iron dextran:North American clinical trial[J]. Am J Kidney Dis,2000,36(1):88-97.
[7]González Z M,Barrasa A G,Lorenzo L R,et al. Intravenous iron[J]. Cir Esp,2009,86(4):196-203.
[8]Harrison P M,Fischbach F A,Hoy T G,et al. Ferric oxyhydroxide core of Ferritin[J]. Nature,1967,216(5121):1188-1190.
[9]Dossabhoy N R,Steven T,Rebecca G,et al. Safety of total dose iron dextran infusion in geriatric patients with chronic kidney disease and iron defi ciency anemia[J]. Renal Fail,2014,36(7):1033-1037.
[10]巴晓雨,赫福,张纲,等. HPLC-ELSD法同时测定黄芪注射液中单糖和蔗糖含量[J].亚太传统医药,2017,13(10):25-27.
[11]国家药典委员会.中华人民共和国药典[M]. 4部.北京:中国医药科技出版社,2015:101-102.
[12]邹桂华,沈广志,崔新刚,等.分光光度法测定野菊花中铁含量[J].微量元素与健康研究,2011,28(1):20-21.