| 分子排阻色谱法测定头孢地尼胶囊中的高分子杂质 |
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| 引用本文： | 全丹,李庆明,葛楠.分子排阻色谱法测定头孢地尼胶囊中的高分子杂质[J].中国药房,2012(41):3912-3913. |
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| 作者姓名： | 全丹 李庆明 葛楠 |
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| 作者单位： | [1]海南三叶美好制药有限公司,海口570216 [2]海口天行健药物研究有限公司,海口570311 |
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| 摘 要： | 目的:建立测定头孢地尼胶囊中高分子杂质的方法。方法:采用分子排阻色谱法。色谱柱为依利特SephadexG-10,以0.025mol·L-1磷酸盐缓冲液(pH7.0)为流动相A(供试品测定),以水为流动相B(对照品测定),流速为1.5mL·min-1,检测波长为254nm。结果:头孢地尼与高分子杂质分离度良好,头孢地尼检测浓度线性范围为3.95～11.85μg·mL-1(r=0.9995),精密度试验RSD=1.67%,检测限为9.9ng。结论:该方法简单、快速、准确、重复性好,可用于头孢地尼胶囊中高分子杂质的检测。
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| 关 键 词： | 头孢地尼胶囊 高分子杂质 分子排阻色谱法 测定 |
Determination of Polymer Impurity in Cefdinir Capsules by Molecular Exclusion Chromatography |
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| QUAN Dan,GE Nan.Determination of Polymer Impurity in Cefdinir Capsules by Molecular Exclusion Chromatography[J].China Pharmacy,2012(41):3912-3913. |
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| Authors: | QUAN Dan GE Nan |
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| Institution: | (Hainan Sanye Meihao Pharmaceutical Co., Ltd., Haikou 570216, China) LI Qing-ming(Haikou Top-sky Pharmaceutical Research Co., Ltd., Haikou 570311, China) |
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| Abstract: | OBJECTIVE： To establish the method for the determination of polymer impurity in Cefdinir capsules. METHODS： Molecular exclusion chromatography was adopted. The chromatographic column was Sephadex G-10 with 0.025 mol. L-1 phosphate buffer （pH 7.0） as mobile phase A （for test sample） and water as mobile phase B （for substance control） at the flow rate of 1.5 mL-min-1 at the detection wavelength of 254 nm. RESULTS： Cefdinir and polymer impurity were separated well. The linear range of cefdinir was 3.95-11.85 μg.mL-1 （r=0.999 5） with RSD of 1.07%, detection limit of 9.9 ng. CONCLUSION： The method is simple, rapid, accurate and reproducible, and it can be used for the determination of polymer impurity in Cefdinir capsules. |
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| Keywords: | Cefdinir capsules Polymer impurity Molecular exclusion chromatography Determination |
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