| 高效液相色谱法测定马来酸伊索拉定片中马来酸伊索拉定含量及含量均匀度 |
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| 引用本文： | 娄月芬,田丰,唐跃年,王斌. 高效液相色谱法测定马来酸伊索拉定片中马来酸伊索拉定含量及含量均匀度[J]. 中国药业, 2011, 20(23): 20-21 |
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| 作者姓名： | 娄月芬 田丰 唐跃年 王斌 |
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| 作者单位： | 1. 上海市第一人民医院分院药剂科,上海,200081
2. 上海交通大学医学院附属新华医院药剂科,上海,200092 |
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| 摘 要： | 目的建立测定马来酸伊索拉定片中马来酸伊索拉定含量及含量均匀度的高效液相色谱法。方法采用Zorbax SB-C8色谱柱(250 mm×4.6 mm,5μm),以0.1%冰醋酸溶液-甲醇(60∶40)为流动相,流速为1.0 mL/min,检测波长为250 nm,柱温为30℃。结果马来酸伊索拉定质量浓度在10～80μg/mL范围内与峰面积呈良好线性关系(r=1.000);平均加样回收率为99.05%,RSD=0.92%(n=9)。结论该方法操作简便、结果准确,可用于该制剂中马来酸伊索拉定的定量分析、含量均匀度检测以及质量控制。
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| 关 键 词： | 马来酸伊索拉定片 高效液相色谱法 含量测定 均匀度 |
Content Determination and Uniformity of Irsogladine Maleate Tablets by HPLC |
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| Lou Yuefen,Tian Feng,Tang Yuenian,Wang Bin. Content Determination and Uniformity of Irsogladine Maleate Tablets by HPLC[J]. China Pharmaceuticals, 2011, 20(23): 20-21 |
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| Authors: | Lou Yuefen Tian Feng Tang Yuenian Wang Bin |
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| Affiliation: | Lou Yuefen1,Tian Feng1,Tang Yuenian2,Wang Bin2(1.Department of Pharmacy,Branch of Shanghai First People's Hospital,Shanghai,China 200081,2.Department of Pharmacy,Xinhua Hospital Affiliated to College of Medicine,Shanghai Jiaotong University,China 200092) |
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| Abstract: | Objective To establish an HPLC method for the determination of irsogladine maleate in Irsogladine Maleate Tablets.Methods The Zorbax SB-C8 column（250 mm×4.6 mm,5 μm）,mobile phase was 0.1%HAc-methanol（60 ∶40）.The flow rate was 1.0 mL/min,the detection wavelength was 250 nm,and the column temperature was 30 ℃.Results The irsogladine maleate had a good linear in the range of 10-80 μg/mL（r=1.000）,the average recovery was 99.05%and RSD was 0.92%（n=9）.Conclusion The established method is accuracy,sensitive and simple.It can be applied in quantitative determination of irsogladine maleate in Irsogladine Maleate Tablets. |
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| Keywords: | Irsogladine Maleate Tablets HPLC content determination uniformity |
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