HPLC法同时测定藿香正气口服液中9种成分的含量
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篇名: HPLC法同时测定藿香正气口服液中9种成分的含量
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摘要: 目的:建立同时测定藿香正气口服液中9种成分含量的方法,提高并完善藿香正气口服液质量标准。方法:采用高效液相色谱(HPLC)法测定10批藿香正气口服液中甘草香豆素、异甘草素、芹糖甘草苷、柚皮芸香苷、甘草苷、川皮苷、橙皮苷、厚朴酚、和厚朴酚9种成分的含量。色谱柱为Kromasil EternityXT-5-C18,流动相为乙腈-0.05%磷酸水溶液(梯度洗脱),流速为1 mL/min,检测波长为220 nm,柱温为25 ℃,进样量为10 μL。结果:甘草香豆素、异甘草素、芹糖甘草苷、柚皮芸香苷、甘草苷、川皮苷、橙皮苷、厚朴酚、和厚朴酚检测质量浓度线性范围分别为0.000 5~0.007 5、0.000 8~0.025 0、0.006 1~0.976 0、 0.001 6~0.250 0、0.007 8~ 0.025 0、0.000 4~0.062 7、0.008 6~0.276 0、0.010 0~0.500 0、0.010 0~0.500 0 mg/mL(r=0.999 2~1.000 0 );检测限分别为0.001 3、0.000 1、0.004 7、0.005 0、0.012 0、0.001 3、0.007 8、0.007 0、0.005 8 μg/mL,定量限分别为0.013 0、0.000 8、0.047 0、0.050 0、0.120 0、0.013 0、0.078 0、0.070 0、0.058 0 μg/mL;精密度、稳定性、重复性试验的RSD均小于3.0%(n=6);平均回收率分别为98.67%、101.85%、98.97%、103.05%、100.00%、97.78%、97.91%、100.13%、101.95%,RSD为1.14%、2.18%、0.40%、0.17%、1.38%、0.85%、1.38%、0.10%、1.35%(n=6)。结论:建立的含量测定方法结果准确、可靠,可为藿香正气口服液整体质量控制评价体系的建立及质量标准的提高提供依据。
ABSTRACT: OBJECTIVE: To establish a method for simultaneous determination of nine components in Huoxiang zhengqi oral liquid, and to improve and perfect the quality standard of Huoxiang zhengqi oral liquid. METHODS: The contents of nine components in 10 batches of Huoxiang zhengqi oral liquid were determined by HPLC, such as licorice coumarin, isorlicin, liquiritinapioside, narirutin, liquiritin, saponins, hesperidin, magnolol and honokiol. The determination was performed on Kromasil Eternity XT-5-C18 column with mobile phase consisted of acetonitrile-0.05% phosphoric acid solution (gradient elution) at the flow rate of 1 mL/min. The detection wavelength was set at 220 nm, and column temperature was 25 ℃. The sample size was 10 μL. RESULTS: The linear range of licorice coumarin, isorlicin, liquiritinapioside, narirutin, liquiritin, saponins, hesperidin, magnolol and honokiolin were 0.000 5-0.007 5, 0.000 8-0.025 0, 0.006 1-0.976 0, 0.001 6-0.250 0, 0.007 8-0.025 0, 0.000 4- 0.062 7, 0.008 6-0.276 0, 0.010 0-0.500 0, 0.010 0-0.500 0 mg/mL (r=0.999 2-1.000 0). The detection limits were 0.001 3, 0.000 1, 0.004 7, 0.005 0, 0.012 0, 0.001 3, 0.007 8, 0.007 7 0, 0.005 8 μg/mL, and the quantitative limits were 0.013 0, 0.000 8, 0.047 0, 0.050 0, 0.120 0, 0.013 0, 0.078 0, 0.070 0, 0.058 0 μg/mL, respectively; RSD of precision, stability and repeatability tests were less than 3.0% (n=6). Average recovery rates were 98.67%, 101.85%, 98.97%, 103.05%, 100.00%, 97.78%, 97.91%, 100.13%, 101.95%; RSDs were 1.14%, 2.18%, 0.40%, 0.17%, 1.38%, 0.85%, 1.38%, 0.10%, 1.35% (n=6). CONCLUSIONS: The established method is accurate and reliable, which can provide reference for the establishment of the overall quality control evaluation system and the improvement of quality standard for Huoxiang zhengqi oral liquid.
期刊: 2019年第30卷第21期
作者: 陈金凤,郭大乐,董自亮,禹奇男,彭涛,李张宇,余佳文,卢庆,姚辰,邓赟,秦少容
AUTHORS: CHEN Jinfeng,GUO Dale,DONG Ziliang,YU Qinan,PENG Tao,LI Zhangyu,YU Jiawen,LU Qing,YAO Chen,DENG Yun,QIN Shaorong
关键字: 藿香正气口服液;HPLC;甘草香豆素;异甘草素;芹糖甘草苷;柚皮芸香苷;甘草苷;川皮苷;橙皮苷;厚朴酚;和厚朴酚;含量测定
KEYWORDS: Huoxiang zhengqi oral liquid; HPLC; Licorice coumarin; Isorlicin; Liquiritinapioside; Narirutin; Liquiritin; Saponins; Hesperidin; Magnolol; Honokiolin; Content determination
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