| HPLC法测定吡菲尼酮片的含量及有关物质 |
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| 引用本文： | 刘和凤,高嵩.HPLC法测定吡菲尼酮片的含量及有关物质[J].中国药师,2011,14(5):669-671. |
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| 作者姓名： | 刘和凤 高嵩 |
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| 作者单位： | 1. 安徽医科大学附属口腔医院药剂科,合肥,230032
2. 合肥信风科技开发有限公司 |
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| 摘 要： | 目的:建立HPLC法测定吡菲尼酮片的含量及有关物质。方法:色谱柱为Kromasil C18柱（250 mm×4.6 mm,5μm）;流动相为乙腈-0.1 mol·L-1磷酸二氢钾缓冲液（34:66）（氢氧化钠调pH至6.8）;流速为1.0 ml·min-1;检测波长为220 nm;柱温为30℃。结果:吡菲尼酮在36.00～180.00μg·ml-1浓度范围线性关系良好（r=0.999 9）,最低检测限0.72 ng,平均回收率为98.75%,RSD=0.50%,各杂质峰与主峰分离良好。结论:本方法简单方便,专属性强,准确可靠,可用于测定吡菲尼酮片的含量及有关物质。
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| 关 键 词： | 高效液相色谱 吡菲尼酮 含量测定 有关物质 |
Determination of the Content and Related Substances Pirfenidone Tablets and its Related Substances by HPLC |
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| Liu Hefeng,Gao Song.Determination of the Content and Related Substances Pirfenidone Tablets and its Related Substances by HPLC[J].China Pharmacist,2011,14(5):669-671. |
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| Authors: | Liu Hefeng Gao Song |
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| Affiliation: | Liu Hefeng~1,Gao Song~2(1.Department of Pharmacy,Affiliated Stomatology Hospital of Anhui Medical University,Hefei 230032,China,2.Hefei Xinfeng Science and Technology Development Co.LTD) |
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| Abstract: | Objective： To establish an HPLC method for the determination of pirfenidone and the related substances in pirfenidone tablets. Method： The analysis was performed on a column of Kromasil C18 （250 mm ×4. 6 mm,5 μm）. The mobile phase consisted of acetonitrile-phosphate buffer （34： 66） （NaOH adjusting pH to 6. 8 ）. The flow rate was 1.0 ml· min ^-1. The detection wavelength was set at 220 nm. The column temperature was 30 ℃. Result： Good linearity was obtained over the range of 36. 00-180. 00 μg·ml^-1 for pirfenidone （r = 0. 999 9）. The limit of detection was 0. 72 ng. The average recovery was 98.75% （RSD = 0. 50% ）. A good separation for pirfenidone and the related substances was achieved. Conclusion： The method is simple,sensitive and accurate,and can be used in the quality control for pirfenidone tablets. |
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| Keywords: | HPLC Pirfenidone tablets Determination Related substances |
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