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作 者:蒋晔[1] 丁翔宇[1] 谢赞[1] 郝福[1] 李艳荣[1] 任淑萌[1]
出 处:《药物分析杂志》2008年第2期284-287,共4页Chinese Journal of Pharmaceutical Analysis
摘 要:目的:建立能够同时快速测定愈创维林那敏胶囊三组分的 RP-HPLC 法。方法:采用 Inertsil C_(18)色谱柱(150 mm×4.6mm,5 μm),以0.5%磷酸溶液(含0.5%三乙胺,氨水调 pH 为5.5)-乙腈(66:34)为流动相,流速为1.0 mL·min^(-1),检测波长为250 nm,柱温为室温。采用外标法计算含量。结果:在一定浓度范围内,愈创甘油醚、枸橼酸喷托维林、马来酸氯苯那敏峰面积与浓度均呈良好的线性关系(r>0.9990)。平均回收率(n=9)分别为100.0%,99.8%,99.6%。结论:该法简便、快速、准确,可用于该制剂的质量控制。Objective:An RP - HPLC method was established for determination of three components rapidly and simultaneously in Yuchuang Weilin Namin capsules for quality control. Methods:Compounds were separated on a Inertsil Cs ( 150 mm ×4. 6 mm,5 μm)column. The mobile phase consisted of 0.5 % phosphoric acid (pH 5.5 ) and acetonitrile (66: 34). The column temperature was at ambient temperature. The analyses were performed at a flow rate of 1.0 mL · min ^- 1 with detection at 250 nm. The external standard method was applied for determination of the three components. Results:The linear calebration curves were obtained over the range of 250 -2500μg · mL^-1 for guaifenesin,25.1 -250. 6μg · mL^-1 for pentoxyverine citrate and 5.1 -50.9μg · mL^-1 for chlorphenamine maleate, respectively. The mean recoveries ( n = 9) of the three compounds were 100. 0%, 99. 8 % and 99. 6%, respectively. Conclusion: The method is simple, rapid, accurate and suitable for quality control of the samples.
关 键 词:愈创维林那敏胶囊 愈创甘油醚 枸橼酸喷托维林 马来酸氯苯那敏 含量测定 RP—HPLC
分 类 号:R917[医药卫生—药物分析学]
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