| HPLC法测定双氯芬酸钠盐酸利多卡因注射液的有关物质 |
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| 引用本文： | 李春盈,张玉英.HPLC法测定双氯芬酸钠盐酸利多卡因注射液的有关物质[J].北方药学,2016,13(9). |
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| 作者姓名： | 李春盈 张玉英 |
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| 作者单位： | 广州市药品检验所 广州 510160;广州市药品检验所 广州 510160 |
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| 摘 要： | 目的：建立HPLC法测定复方制剂双氯芬酸钠盐酸利多卡因注射液中的有关物质。方法：采用反相高效液相色谱法，以自身对照法计算双氯芬酸钠盐酸利多卡因注射液有关物质的量。用C18（250mm×4.6mm，5μm）色谱柱，以甲醇-4%冰醋酸溶液（65∶35）为流动相，流速1.0mL/min，于波长为245nm处检测。结果：双氯芬酸钠与利多卡因杂质完全分离，有关物质的线性回归方程为A=22.139×C+2.3422，相关系数为r=0.9995（n=5）；方法的最低检出限为0.0089%。结论：实验证明该法简便快捷，能准确地测定样品的有关物质。
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| 关 键 词： | 反相高效液相色谱法 双氯芬酸钠盐酸利多卡因注射液 有关物质 |
Determination of Diclofenac sodium and Lidocaine Hydrochloride Injection related substances by HPLC |
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| Li Chunying,Zhang Yuying.Determination of Diclofenac sodium and Lidocaine Hydrochloride Injection related substances by HPLC[J].BEIFANG YAOXUE,2016,13(9). |
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| Authors: | Li Chunying Zhang Yuying |
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| Abstract: | Objective: To establish a HPLC method for the determination of Diclofenac sodium and Lidocaine Hydrochloride Injection related substances. Methods:The sample was analyzed on a C18(250mm×4.6mm,5μm)column with mobile phase consisting of methonal-4% Acetic Acid (65∶35). The flow rate was 1.0mL/min and the detection wavelength was 245nm. Results: The peaks of Diclofenac, Lidocaine and its impurities were completely separated. The regression equation for related substances was A=22.139 ×C+2.3422,r=0.9995 (n=5). The detection limit was 0.0089%. Conclusions: This method is convenient, quick and reproducible for the quantitative determination of Diclofenac sodium and Lidocaine Hydrochloride Injection in the related substances. |
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| Keywords: | HPLC Diclofenac sodium and Lidocaine Hydrochloride Injection Related substances |
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