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

Jung-Hoon Kim, Chang-Seob Seo, Hyeun-Kyoo Shin

Index: Arch. Pharm. Res. 38(1) , 52-62, (2015)

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Abstract

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 μg/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.