| HPLC法测定复方硫酸双肼屈嗪片的有关物质 |
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| 引用本文： | 吴珺,蔡鹏. HPLC法测定复方硫酸双肼屈嗪片的有关物质[J]. 中国药事, 2011, 25(12): 1222-1224 |
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| 作者姓名： | 吴珺 蔡鹏 |
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| 作者单位： | 江苏省泰州药品检验所,泰州,225300 |
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| 摘 要： | 目的建立HPLC法测定复方硫酸双肼屈嗪片的有关物质。方法采用Aglient Eclipse XDB-CN柱,流动相为乙腈-0.01mol.L-1庚烷磺酸钠溶液(用20%磷酸调节pH至2.7)(30∶70),流速为0.8mL.min-1,检测波长308nm。结果主峰与各降解产物峰的分离良好,方法的精密度良好。结论本方法简便、准确、灵敏度高,可用于复方硫酸双肼屈嗪片的有关物质的检查。
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| 关 键 词： | 复方硫酸双肼屈嗪片 HPLC 有关物质 |
Determination of Related Substances of Compound Dihydralazine Sulfate Tablets by HPLC |
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| Wu Jun,Cai Peng. Determination of Related Substances of Compound Dihydralazine Sulfate Tablets by HPLC[J]. Chinese Pharmaceutical Affairs, 2011, 25(12): 1222-1224 |
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| Authors: | Wu Jun Cai Peng |
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| Affiliation: | Wu Jun and Cai Peng(Taizhou Institute for Drug Control of Jiangsu Province,Taizhou 225300) |
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| Abstract: | Objective To establish a method to determine the related substances in Compound Dihydralazine Sulfate Tablets by HPLC.Methods The HPLC column was Aglient Eclipse XDB-CN column;the mobile phase was acetonitrile-0.01mol·L-1 sodium heptane sulfonate solution（adjust to pH 2.7 with 20% phosphoric acid solution）（30∶70）;the flow rate was 0.8mL·min-1;the detection wavelength was 308 nm.Results Dihydralazine Sulfate and Hydrochlorothiazide were separated well from the related substances.The reproducibility and precision of the method were good.Conclusion The method is simple,accurate and sensitive.It can be used for the determination of the related substances of Compound Dihydralazine Sulfate Tablets. |
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| Keywords: | Compound Dihydralazine Sulfate Tablets HPLC related substances |
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