Analytical Sciences

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

Liangmian CHEN,*1,*2,*3 Akira KOTANI,*1 Hideki HAKAMATA,*1 Risa TSUTSUMI,*1 Yuzuru HAYASHI,*4 Zhimin WANG,*2,*3 and Fumiyo KUSU*1

*1 School of Pharmacy, Tokyo University of Pharmacy and Life Sciences, Tokyo 192-0392, Japan
*2 Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, P. R. China
*3 National Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicine, Beijing 100700, P. R. China
*4 Teikyo Heisei University, 4-21-2 Nakano, Nakano, Tokyo 164-8530, Japan

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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