HPLC法测定小儿白贝止咳糖浆中原阿片碱的含量
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摘要
目的:建立小儿白贝止咳糖浆中原阿片碱的含量测定方法。方法:采用高效液相色谱法测定,色谱条件为:Agilent TC C_(18)色谱柱(4.6 mm×250 mm,5μm),流动相为乙腈-三乙胺醋酸溶液(18∶82),流速1 mL·min~(-1),检测波长289 nm,柱温30℃。结果:原阿片碱在0.139 5～2.232 3μg范围内线性关系良好(r=0.999 8),平均回收率99.14%(RSD=0.82%)。3批样品含量测定结果:平均含量为6.6μg·mL~(-1)。结论:本方法简便、准确、重现性好,可以作为小儿白贝止咳糖浆的控制方法。
Objective: To establish a method for content determination of protopine in Xiao′er Baibei Zhike syrup. Methods: The HPLC determination was performed in Agilent TC C_(18) column(4.6 mm×250 mm, 5 μm). The mobile phase was acetonitrile-acetic triethylamine solution(18∶82), the flow rate was 1.0 mL·min~(-1), the detector wavelength was set at 289 nm and the column temperature was maintained at 30 ℃. Results: The linear range of protopine fell into 0.139 5-2.232 3 μg(r=0.999 8) with the average recovery as 99.14%(RSD=0.82%). The average content of protopine in 3 batches of samples were 6.6 μg·mL~(-1). Conclusion: The established method is simple, accurate, and reproducible, and it can be used for quality control of Xiao′er Baibei Zhike syrup.
Objective: To establish a method for content determination of protopine in Xiao′er Baibei Zhike syrup. Methods: The HPLC determination was performed in Agilent TC C_(18) column(4.6 mm×250 mm, 5 μm). The mobile phase was acetonitrile-acetic triethylamine solution(18∶82), the flow rate was 1.0 mL·min~(-1), the detector wavelength was set at 289 nm and the column temperature was maintained at 30 ℃. Results: The linear range of protopine fell into 0.139 5-2.232 3 μg(r=0.999 8) with the average recovery as 99.14%(RSD=0.82%). The average content of protopine in 3 batches of samples were 6.6 μg·mL~(-1). Conclusion: The established method is simple, accurate, and reproducible, and it can be used for quality control of Xiao′er Baibei Zhike syrup.
引文
[1] 中华人民共国药典2015年版.一部[S].2015:1240ChP 2015.VolⅠ[S].2015:1240
[2] 蒋遐芝,叶锦霞,曾建伟,等.HPLC测定小花黄堇中原阿片碱的含量[J].中国中药杂志,2010,35(17):2315JIANG XZ,YE JX,ZENG JW,et al.Determination of protopine in Corydalis racemose by HPLC[J].China J Chin Mater Med,2010,35(17):2315
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[7] 熊蔚,李艳明.HPLC法测定小儿白贝止咳合剂中原阿片碱的含量[J].药物分析杂志,2008,28(9):1538XIONG W,LI YM.HPLC determination of protopine in Xiao′er Baibei Zhike mixture[J].Chin J Pharm Anal,2008,28(9):1538
[8] 张明淑,李梅,古冉锋,等.HPLC法测定小儿发白贝止咳糖浆中原阿片碱的含量[J].中国药师,2010,13(2):208LI MS,LI M,GU RF,et al.Determination of protopine in Child Baibei Anti-Cough Syrup by HPLC[J].China Pharm,2010,13(2):208
[9] 卫生部药品标准.中药成方制剂第二十册[S].1998:18Drug Specifications Promulgated by the Ministry of Public Health.PR China.Chinese Medicine Prescription Preparation Volume 20[S].1998:18
[2] 蒋遐芝,叶锦霞,曾建伟,等.HPLC测定小花黄堇中原阿片碱的含量[J].中国中药杂志,2010,35(17):2315JIANG XZ,YE JX,ZENG JW,et al.Determination of protopine in Corydalis racemose by HPLC[J].China J Chin Mater Med,2010,35(17):2315
[3] 李俊芳,黄飞龙,郑艳春,等.HPLC测定胃舒止痛片中原阿片碱的含量[J].中国现代中药,2012,14(12):47LI JF,HUANG FL,ZHENG YC,et al.Determination of protopine in Weishu Zhitong Tablets by HPLC[J].Mod Chin Med,2012,14(12):47
[4] 蒋珍藕,兰宝强,邱宏聪,等.儿童咳糖浆质量标准研究[J].中国现代中药,2011,13(6):39JIANG ZO,LAN BQ,QIU HC,et al.Study on quality standard for Ertong Ke Tangjiang [J].Mod Chin Med,2011,13(6):39
[5] 苏玉严,周海妹,展学孔,等.HPLC法测定夏天无薄膜衣片中原阿片碱的含量[J].中国药房,2010,21(36):3445SU YY,ZHOU HM,ZHAN XK,et al.Content determination of protopine in Corydalis Decumbens Film-coated Tablets by HPLC[J].China Pharm,2010,21(36):3445
[6] 中华人民共国药典2015年版.一部[S].2015:109ChP 2015.VolⅠ[S].2015:109
[7] 熊蔚,李艳明.HPLC法测定小儿白贝止咳合剂中原阿片碱的含量[J].药物分析杂志,2008,28(9):1538XIONG W,LI YM.HPLC determination of protopine in Xiao′er Baibei Zhike mixture[J].Chin J Pharm Anal,2008,28(9):1538
[8] 张明淑,李梅,古冉锋,等.HPLC法测定小儿发白贝止咳糖浆中原阿片碱的含量[J].中国药师,2010,13(2):208LI MS,LI M,GU RF,et al.Determination of protopine in Child Baibei Anti-Cough Syrup by HPLC[J].China Pharm,2010,13(2):208
[9] 卫生部药品标准.中药成方制剂第二十册[S].1998:18Drug Specifications Promulgated by the Ministry of Public Health.PR China.Chinese Medicine Prescription Preparation Volume 20[S].1998:18