HPLC法测定磺丁基醚-β-环糊精中杂质β-环糊精的含量
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摘要
目的建立磺丁基醚-β-环糊精(SBE-β-CD)中杂质β-环糊精(β-CD)的含量测定方法。方法采用高效液相色谱法,色谱柱为Agilent ZORBAX SB-C_(18)(4. 6 mm×250 mm,5μm)柱;流动相为甲醇-水(10∶90);流速为1 ml/min;蒸发光散射检测器,柱温:30℃;漂移管温度70℃;气体(N2)压力30 psi。结果在该色谱条件下,SBE-β-CD和β-CD能完全分离;β-CD在0. 078 23～0. 234 7 mg/ml的浓度范围内线性关系良好(r=0. 994 7);平均加样回收率为105. 8%(RSD=4. 8%)。结论本方法简便快速、灵敏准确,可用于磺丁基醚-β-环糊精中β-环糊精的测定。
Objective To develop an HPLC method for the determination of β-CD in SBE-β-CD. Methods The seperation was accomplished on an Agilent ZORBAX SB-C_(18) column (4. 6 mm × 250 mm,5 μm) using a mixture of methanol-water (10∶ 90) as the mobile phase at a flowrate of 1. 0 ml/min. The column temperature was kept at30 ℃,the drift tube temperature was 70 ℃ and nebulizer gas (N2) pressure was 30 psi. Results Under the established chromatographic conditions,SBE-β-CD and β-CD could be separated completely. The linear range of β-CD curve was 0. 078 23 ～ 0. 234 7 mg/ml with the correlation coefficient of 0. 994 7. The average recovery was 105. 8% (RSD = 4. 8%). Conclusion The method is simple and accurate,which can be applied to determine the content of β-CD in SBE-β-CD.
Objective To develop an HPLC method for the determination of β-CD in SBE-β-CD. Methods The seperation was accomplished on an Agilent ZORBAX SB-C_(18) column (4. 6 mm × 250 mm,5 μm) using a mixture of methanol-water (10∶ 90) as the mobile phase at a flowrate of 1. 0 ml/min. The column temperature was kept at30 ℃,the drift tube temperature was 70 ℃ and nebulizer gas (N2) pressure was 30 psi. Results Under the established chromatographic conditions,SBE-β-CD and β-CD could be separated completely. The linear range of β-CD curve was 0. 078 23 ～ 0. 234 7 mg/ml with the correlation coefficient of 0. 994 7. The average recovery was 105. 8% (RSD = 4. 8%). Conclusion The method is simple and accurate,which can be applied to determine the content of β-CD in SBE-β-CD.
引文
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[3]冯彩霞,修宪,田伟,等.伏立康唑磺丁基醚-β-环糊精包合物制备工艺优化[J].中国医院药学杂志,2017,37(15):1431-1434.
[4]蒋娟,陈萌萌,王淼,等.泊沙康唑-磺丁基-β-环糊精包合物的制备[J].沈阳药科大学学报,2016,33(7):519-524.
[5]曹雅培,王静,曹德英.药用辅料磺丁基醚-β-环糊精在不同制剂中的应用进展[J].中国药房,2012,23(1):79-82.
[6]谢佳蓉,涂家生,孙春萌.盐酸非索非那定磺丁基醚-β-环糊精包合物鼻用温敏凝胶的制备及黏附效果评价[J].中国药房,2016,27(28):3961-3963.
[7]孙宏晟,王建华.甲氧苄啶-磺丁基醚-β-环糊精包合物的制备、表征及分子模拟[J].中国医院药学杂志,2017,52(13):1159-1166.
[8]于嘉鑫,刘子列,任勇,等.高效液相色谱法测定磺丁基β-环糊精中的β-环糊精残留含量[J].药物分析杂志,2011,31(4):749-751.
[9]王川,张燕,李楠,等.HPSEC-ELSD法同时测定白及多糖的分子量和含量[J].中国药房,2018,29(9):1198-1201.
[10]林冬梅,罗虹建,王赛贞,等.HPLC-ELSD检测灵芝多糖肽的方法[J].海峡药学,2018,30(5):29-32.
[11]杨俊,刘江生,蔡继宝,等.高效液相色谱-蒸发光散射检测法测定烟草中的水溶性糖[J].分析化学研究简报,2005,33(11):1596-1598.
[12]李咏华,黄裕,杨中铎,等.高效液相色谱法测定巴戟天中低聚糖含量[J].药物分析杂志,2007,27(11):1797-1799.
[13]李先端,钟银燕,顾雪竹,等.中药炮制辅料蜂蜜中葡萄糖、果糖、蔗糖的含量测定[J].中成药,2008,30(6):885-888.