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Development of validated determination of the eleven marker compounds in Gyejibokryeong-hwan for the quality assessment using HPLC analysis

机译:建立高效液相色谱(HPLC)分析法测定桂枝粉岭中11种标记化合物的质量验证方法

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摘要

This study was designed for quality assessment of Gyejibokryeong-hwan (GBH) preparations using the simultaneous determination of 11 marker compounds such as gallic acid, oxypaeoniflorin, amygdalin, albiflorin, paeoniflorin, benzoic acid, coumarin, cinnamic acid, benzoylpaeoniflorin, cinnamaldehyde, and paeonol using HPLC-PDA and chemometric analysis. The correlation coefficient of linear regression was > 0.9993. The LOD and LOQ values were in the ranges of 0.02-2.11 and 0.06-7.34 mu g/mL, respectively. The intra-day and inter-day precision was 0.07-4.76 and 0.04-5.08 %, and the recovery range was 92.19-103.24 %, with RSD values < 4.5 %. The repeatability of the 11 marker compounds was < 2.5 % of the RSD values. The results of quantification indicated that there was much variation in the content of the 11 marker compounds among the GBH preparations. Amygdalin and paeoniflorin were detected in high quantities in all GBH samples, whereas some compounds such as cinnamaldehyde and paeonol were not detected in GBH samples from the Korean manufacturers. The content of marker compounds in the laboratory GBH water extract was different to the commercial preparations. Results of analyses carried out with the method indicate the need for quality control of GBH preparations.
机译:本研究旨在通过同时测定11种标记化合物(例如没食子酸,羟药苷,苦杏仁苷,白花精,pa药苷,苯甲酸,香豆素,肉桂酸,苯甲酰pa药苷,肉桂醛和pa药)来同时测定11种标记化合物,从而对Gyejibokryeong-hwan(GBH)制剂进行质量评估。使用HPLC-PDA和化学计量分析。线性回归的相关系数> 0.9993。 LOD和LOQ值分别在0.02-2.11和0.06-7.34μg / mL的范围内。日内和日间精度为0.07-4.76和0.04-5.08%,回收率范围为92.19-103.24%,RSD值<4.5%。 11种标记化合物的重复性小于RSD值的2.5%。定量结果表明,GBH制剂中11种标记化合物的含量差异很大。在所有GBH样品中都检出了大量苦杏仁苷和pa药苷,而韩国制造商的GBH样品中未检出肉桂醛和pa药等某些化合物。实验室GBH水提取物中的标志物含量与市售制剂不同。用该方法进行的分析结果表明需要对GBH制剂进行质量控制。

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