| 引用本文: | 罗淑青,卓开华,周征,曹琳.HPLC测定甘氨双唑钠中的有关物质[J].中国现代应用药学,2014,31(11):1374-1376. |
| LUO Shuqing,ZHUO Kaihua,ZHOU Zheng,CAO Lin.Determination of Related Substance in Glycididazole Sodium by HPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2014,31(11):1374-1376. |
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| 摘要: |
| 目的 建立高效液相色谱法测定甘氨双唑钠中的有关物质。方法 采用资生堂 CAPCELL C18色谱柱(250 mm×4.6 mm，5 μm)色谱柱，以0.05 mol·L-1醋酸铵溶液(用氢氧化钠试液调pH值至7.1)-乙腈(80∶20)为流动相，流速：1.0 mL·min-1, 检测波长：316 nm，柱温：35 ℃，进样量：20 μL。结果 甘氨双唑钠及其相关杂质均能较好分离。甘氨双唑钠在0.46~18.42 μg·mL-1内线性关系良好(r=0.999 9)，甲硝唑在0.04~20.12 μg·mL-1内线性关系良好(r=1.000 0)，平均回收率为98.81%(RSD=0.90%)。结论 本方法灵敏，准确，专属性强，可用于甘氨双唑钠中有关物质的测定。 |
| 关键词: 甘氨双唑钠 有关物质 甲硝唑 |
| DOI： |
| 分类号:R284.1；R917.101 |
| 基金项目:国家药品标准提高研究课题(附件2-266) |
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| Determination of Related Substance in Glycididazole Sodium by HPLC |
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LUO Shuqing, ZHUO Kaihua, ZHOU Zheng, CAO Lin
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Ningbo Institute for Drug Control, Ningbo 315048, China
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| Abstract: |
| OBJECTIVE To establish an HPLC method to determine the related-substance of glycididazole sodium. METHODS The assay was conducted on a CAPCELL ODS column (250 mm×4.6 mm, 5 μm) with 0.05 mol·L-1 solution of ammonium acetate buffer (adjust to pH 7.1 with sodium hydroxide )-acetonitrile (80∶20) as mobile phase at the flow rate of 1.0 mL·min-1, the detection wavelength was set at 316 nm, temperature was 35 ℃, and the injection volume was 20 μL. RESULTS Glycididazole sodium was completely separated from impurities. The linear concentration range of glycididazole sodium was 0.46-18.42 μg·mL-1 with the correlation coefficient of 0.999 9. And the linear concentration range of metronidazole was 0.04-20.12 μg·mL-1 with the correlation coefficient of 1.000 0, the average recovery was 98.81%(RSD=0.90%). CONCLUSION The method is sensitive, accurate and specific. It can be used to determine related-substance in glycididazole sodium. |
| Key words: glycididazole sodium related-substance metronidazole |
