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Repeatability Assessment by ISO 11843-7 in Quantitative HPLC for Herbal Medicines

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We have proposed an assessment methods to estimate the measurement relative standard deviation (RSD) of chromatographic peaks in quantitative HPLC for herbal medicines by the methodology of ISO 11843 Part 7 (ISO 11843- 7:2012), which provides detection limits stochastically. In quantitative HPLC with UV detection (HPLC-UV) of Scutellaria Radix for the determination of baicalin, the measurement RSD of baicalin by ISO 11843-7:2012 stochastically was within a 95% confidence interval of the statistically obtained RSD by repetitive measurements (n = 6). Thus, our findings show that it is applicable for estimating of the repeatability of HPLC-UV for determining baicalin without repeated measurements. In addition, the allowable limit of the “System repeatability” in “Liquid Chromatography” regulated in a pharmacopoeia can be obtained by the present assessment method. Moreover, the present assessment method was also successfully applied to estimate the measurement RSDs of quantitative three-channel liquid chromatography with electrochemical detection (LC-3ECD) of Chrysanthemi Flos for determining caffeoylquinic acids and flavonoids. By the present repeatability assessment method, reliable measurement RSD was obtained stochastically, and the experimental time was remarkably reduced.

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This research is supported in part by the Grants-in-Aid for Scientific Research C (No. 26410161 to A. K.) from the Ministry of Education, Culture, Sports, Science, and Technology of Japan, the Special Project for Traditional Chinese Medicine Industry (No. 201307008-04), and the research fund from the China Academy of Chinese Medical Science (ZZ2014055). Liangmian Chen, one of the authors, would also like to express his gratitude to the international exchange program between the China Academy of Chinese Medical Science and the School of Pharmacy, Tokyo University of Pharmacy and Life Sciences.

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Correspondence to Fumiyo Kusu.

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Chen, L., Kotani, A., Hakamata, H. et al. Repeatability Assessment by ISO 11843-7 in Quantitative HPLC for Herbal Medicines. ANAL. SCI. 31, 903–909 (2015).

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