| HPLC法测定罗氟司特片中的有关物质 |
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| 引用本文： | 刘婷,张露勇,刘师卜,张斗胜. HPLC法测定罗氟司特片中的有关物质[J]. 药学研究, 2017, 36(6): 322-326. DOI: 10.13506/j.cnki.jpr.2017.06.004 |
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| 作者姓名： | 刘婷 张露勇 刘师卜 张斗胜 |
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| 作者单位： | 中国食品药品检定研究院,北京,100050 |
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| 摘 要： | 目的 建立高效液相色谱法测定罗氟司特片的有关物质.方法 采用Zorbax SB-C18(4.6 mm×150 mm,5 μm)色谱柱,0.005 mol·L-1磷酸二氢钾溶液-乙腈为流动相,梯度洗脱,流速为1.0 mL·min-1,检测波长为250 nm.结果 罗氟司特及各杂质在相应的浓度范围内,峰面积与浓度均呈良好的线性关系,相关系数均大于0.999.结论 建立的方法快速、灵敏、准确,适用于罗氟司特片中的有关物质测定.
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| 关 键 词： | 罗氟司特 片剂 有关物质 高效液相色谱法 |
Determination of related substances in Roflumilast Tablets by HPLC method |
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| LIU Ting,ZHANG Luyong,LIU Shibu and ZHANG Dousheng. Determination of related substances in Roflumilast Tablets by HPLC method[J]. Journal of Pharmaceutical Research, 2017, 36(6): 322-326. DOI: 10.13506/j.cnki.jpr.2017.06.004 |
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| Authors: | LIU Ting ZHANG Luyong LIU Shibu ZHANG Dousheng |
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| Affiliation: | National Institutes for Food and Drug Control,Beijing 100050,China,National Institutes for Food and Drug Control,Beijing 100050,China,National Institutes for Food and Drug Control,Beijing 100050,China and National Institutes for Food and Drug Control,Beijing 100050,China |
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| Abstract: | Objective To establish a method for the determination of related substances in Roflumilast Tablets by HPLC method.Methods A Zorbax SB-C18 (4.6 mm×150 mm,5 μm)column was adopted,the mobile phase was consisted of 0.005 mol·L-1potassium dihydrogen phosphate-acetonitrile with gradient elution at a flow rate of 1.0 mL·min-1,and the detection wavelength was 250 nm.Results In the appropriate concentration range,roflumilast and the impurities peak area showed a good linear relationship with the concentration,the correlation coefficients were greater than 0.999.Conclusion The method was rapid,sensitive,accurate,and suitable for the determination of related substances in Roflumilast Tablets. |
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| Keywords: | Roflumilast Tablets Related substances HPLC |
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