| 孟鲁司特钠片降解产物的HPLC法测定研究 |
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| 引用本文： | 王益华,俞俊萍,来丽丽.孟鲁司特钠片降解产物的HPLC法测定研究[J].中外医疗,2014,0(8):23-24,113. |
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| 作者姓名： | 王益华 俞俊萍 来丽丽 |
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| 作者单位： | 王益华(杭州民生滨江制药有限公司,浙江杭州,310000)；俞俊萍(杭州民生滨江制药有限公司,浙江杭州,310000)； 来丽丽 (浙江中医药大学生物工程学院,浙江杭州,310053)； |
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| 摘 要： | 目的探讨孟鲁司特钠片降解产物的测定方法，以有效控制药品的质量。方法采用用高效液相色谱法测定孟鲁司特钠片降解产物，Agilent ZORBAX XDB C8色谱柱（4．6mm×250mm，5μm），以磷酸盐缓冲液为流动相A，乙腈为流动相B梯度洗脱，流速1．2mL／min，检测波长为254nm，采用杂质对照品法测定降解产物。结果孟鲁司特钠浓度在1．035648—6．213888μg／mL范围内与峰面积呈良好的线性关系，主药与降解产物能达到较好的基线分离。结论该方法灵敏度高，专属性强，准确可靠，可用于药品控制。
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| 关 键 词： | 高效液相色谱法 孟鲁司特钠 降解产物 |
Study on HPLC for the Determination of Montelukast Sodium Tablets Degradation Products |
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| WANG Yihua,YU Junpingl,LAI Lili.Study on HPLC for the Determination of Montelukast Sodium Tablets Degradation Products[J].China Foreign Medical Treatment,2014,0(8):23-24,113. |
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| Authors: | WANG Yihua YU Junpingl LAI Lili |
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| Affiliation: | 1. Hangzhou Minsheng Pharmaceutical Group Co., Ltd, Hangzhou, 310051, Zhejiang Province, China; 2. College of Bioengineering, Zhejiang Chinese Medical University, Hangzhou, Zhejiang Province, 310053, China) |
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| Abstract: | Objective To investigate a method for the determination of montelukast sodium tablets degradation products, in order to effectively control the quality of drugs. Methods HPLC for determination of montelukast sodium tablets degradation product, Agilent ZORBAX XDB C8 column （4.6 × 250mm, 5 μm）, phosphate buffer as mobile phase A, acetonitrile as mobile phase B gradient elution, flow rate 1.2ml/min, the detection wavelength was 254nm, the impurity determination of degradation products in the control sample method. Results Montelukast sodium concentration in the range of 1.035648- 6.213888 μ g/ml had a good linear relationship with peak area, the main drug and degradation products can achieve good baseline separation. Conclusion This method is of high sensitivity, strong specificity, accurate and reliable, and can be used for drug control. |
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| Keywords: | HPLC Montelukast sodium Degradation products |
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