| 徐佳,段希英.HPLC-CAD法同时测定氨糖美辛肠溶片中两种成分的含量[J].中国药品标准,2023,24(1): |
| HPLC-CAD法同时测定氨糖美辛肠溶片中两种成分的含量 |
| Simultaneous determination of two components in glucosamine indomethacin enteric-coated tablets by HPLC-CAD |
| 投稿时间：2021-10-23 修订日期：2023-02-01 |
| DOI： |
| 中文关键词: 氨糖美辛肠溶片 高效液相色谱-电喷雾检测器 吲哚美辛 盐酸氨基葡萄糖 t检验 |
| 英文关键词: glucosamine indomethacin enteric-coated tablets HPLC-CAD indomethacin glucosamine hydrochloride t-test |
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| 摘要点击次数: 327 |
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| 中文摘要: |
| 目的：对于现行标准中氨糖美辛肠溶片含量测定步骤繁琐,氨基柱柱效下降快等问题,建立一种高效液相色谱-电喷雾检测器(HPLC-CAD)同时测定两种主成分的方法。方法：色谱柱：Waters XBridge-C18(4.6 mm×250 mm,5μm),流动相A为 0.1% 冰醋酸溶液,流动相B为乙腈,采用梯度洗脱的方式,流速为0.7 mL.min-1,柱温：30 ℃,进样量：20μL,检测器为CAD(雾化温度：45℃；数据采集频率：10Hz；滤光片：10.0s)。结果：供试品溶液中两主峰达到基线分离,阴性溶液中辅料峰与主峰无干扰。吲哚美辛和盐酸氨基葡萄糖线性范围分别为0.0125-0.25mg.mL-1和0.0375-0.75mg.mL-1,加样回收率分别为100.00%-102.21%、98.74%-101.90%,统计学t检验结果显示该方法与药典标准方法的测定结果无显著差异。结论：该方法具有操作简便,灵敏度高,专属性强,可作为氨糖美辛肠溶片的含量测定替代方法。 |
| 英文摘要: |
| Objective： in order to solve the problems of the cumbersome and the efficiency of amino column decreasing rapidly in the determination of the content of glucosamine indomethacin enteric-coated tablets in the current standard, a high-performance liquid chromatography-charged aerosol detector (HPLC-CAD) method was established to simultaneously determine the two main components. Method: Waters XBridge-C18 (4.6 mm×250 mm, 5μm) was used with 0.1% glacial acetic acid (mobile phase A) and acetonitrile(mobile phase B) at the flow rate of 0.7 mL.min-1, and gradient elution method was used. The column temperature was set at 30℃ and injection volume was 20μL. The detector is CAD (atomization temperature: 45℃; data collection frequency: 10Hz; filter: 10.0s). Results: The two main peaks in the test solution had reached baseline separation, and there was no interference between the auxiliary peak and the main peak. The linear ranges of indomethacin and glucosamine hydrochloride were 0.0125-0.25mg.mL-1 and 0.0375-0.75mg.mL-1, and the recoveries were 100.00%-102.21% and 98.74%-101.90%, respectively. There was no significant difference between the method and pharmacopoeia standard through the statistical t-test. Conclusion: The method shows simple operation, high sensitivity and strong specificity, and was an alternative method for determining the content of glucosamine indomethacin enteric-coated tablets. |
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