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

Archives of pharmacal research (2014-03-13)
Jung-Hoon Kim, Chang-Seob Seo, Hyeun-Kyoo Shin
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.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Acetonitrile solution, contains 0.035 % (v/v) trifluoroacetic acid, suitable for HPLC
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Coumarin, ≥98%
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Amygdalin, BioXtra, ≥97.0% (HPLC)
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Amygdalin, from apricot kernels, ≥99%
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Cinnamaldehyde, natural, ≥95%, FG
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Mettler-Toledo Calibration substance ME 18555, Benzoic acid, analytical standard, for the calibration of the thermosystem 900, traceable to primary standards (LGC)
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Acetonitrile solution, contains 10.0% acetone, 40.0% 2-propanol, 0.05% formic acid
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Acetonitrile solution, contains 0.05 % (w/v) ammonium formate, 0.1 % (v/v) formic acid, 5 % (v/v) water, suitable for HPLC
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Acetonitrile solution, contains 0.05 % (v/v) trifluoroacetic acid
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Acetonitrile solution, contains 0.1 % (v/v) trifluoroacetic acid, suitable for HPLC
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Acetonitrile solution, contains 0.1 % (v/v) formic acid, suitable for HPLC
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Coumarin, certified reference material, TraceCERT®
Coumarin, primary reference standard
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Coumarin, ≥99% (HPLC)
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Residual Solvent - Acetonitrile, Pharmaceutical Secondary Standard; Certified Reference Material
Coumarin, European Pharmacopoeia (EP) Reference Standard
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Acetonitrile, ACS reagent, ≥99.5%
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Acetonitrile, suitable for DNA synthesis, ≥99.9% (GC)
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Acetonitrile, biotech. grade, ≥99.93%
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Acetonitrile, suitable for HPLC, gradient grade, ≥99.9%
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Acetonitrile, suitable for HPLC-GC, ≥99.8% (GC)
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Acetonitrile, HPLC Plus, ≥99.9%
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Acetonitrile, suitable for HPLC, gradient grade, ≥99.9%
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Acetonitrile, puriss. p.a., ACS reagent, reag. Ph. Eur., ≥99.5% (GC)
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Acetonitrile, ReagentPlus®, 99%
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Gallic acid, 97.5-102.5% (titration)
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trans-Cinnamaldehyde, analytical standard
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Acetonitrile, anhydrous, 99.8%
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Benzoic acid, ACS reagent, ≥99.5%
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