摘要
目的 建立同时测定布洛伪麻颗粒剂中布洛芬和盐酸伪麻黄碱含量的反相HPLC测定法。方法 以双氯芬酸为内标;色谱柱为Shim-pack CLC-DOS柱,流动相为甲醇-磷酸盐缓冲液(含0.05 mol·L-1磷酸二氢钾和0.01 mol·L-1磷酸氢二钾)(64∶36),流速为1.0 ml·min-1,定时程序控制检测波长(0~6 min为215 nm,6~10 min为260 nm);进样量20 μl。结果 布洛芬和盐酸伪麻黄碱分别在0.02~0.40 mg·ml-1和3.0~60.0 μg·ml-1范围内线性关系良好,相关系数分别为r=0.9997和r=0.9998。两组分的回收率分别介于98.02%~101.12%和97.71%~101.15%之间,日内和日间 RSD 均低于5%。结论 本法可同时测定布洛伪麻颗粒剂中布洛芬和盐酸伪麻黄碱的含量,而且简便、准确、快速,可用于多批样品的含量测定及质量控制。
Abstract
OBJECTIVE To establish a reversed-phase HPLC method for the simultaneous determination of ibuprofen(Ibu) and pseudoephedrine hydrochloride (PEH) in ibuprofen and pseudoephedrine hydrochloride granules.METHODS With diclofenac as the internal standard,the contents of Ibu and PEH were assayed on a Shim-pack CLC-ODS column with a mobile phase composed of methonal-phosphate buffer solution (consisting of 0.05 mol·L-1KH2PO4and 0.01 mol·L-1K2HPO4)(64∶36) at a flow rate of 1.0 ml·min-1.The detection wavelength was 215 nm between 0~6 min and 260 nm between 6~10 min,which was controlled with a timing program.RESULTS The linear ranges of Ibu and PEH were 0.02~0.40 mg·ml-1(r=0.9997) and 3.0~60.0 μg·ml-1(r=0.9998) respectively.And the recoveries of these two components were within 98.02%~101.12% and 97.71%~101.15% respectively.The intra-day and inter-day RSD of Ibu and PEH were all less than 5%.CONCLUSION This method was a simple,rapid and accurate assay,and suitable for quality control of large amounts of samples.
关键词
HPLC /
布洛芬 /
盐酸伪麻黄碱
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Key words
HPLC /
ibuprofen /
pseudoephedrine hydrochloride /
diclofenac
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李娟 高允华 高允生 李兴贵.
HPLC同时测定布洛伪麻颗粒剂中布洛芬和伪麻黄碱含量[J]. 中国药学杂志, 2000, 35(09): 623-624
LI Jun;GO Yun-hu;GO Yun-sheng;LI Xing-gui.
Simultaneous determination of ibuprofen and pseudoephedrine in ibuprofen and pseudoephedrine hydrochloride granules by HPLC assay[J]. Chinese Pharmaceutical Journal, 2000, 35(09): 623-624
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参考文献
[1]Sen AK,Bandyopadhyay A,Podder G,et al.Reversed-phase high performance liquid chromatographic determination of ibuprofen and ethambutol in pharmaceutical dosage foem[J].J Indian Chem Soc,1990,67(5):443.
[2]郭平,项进.用HPLC测定复方感冒片中伪麻黄碱、扑热息痛、美沙芬和扑尔敏的含量[J].中国新药杂志,1995,4(2):51.
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脚注
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