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Current quality control of Inonotus obliquus requires chromogen complex content limit of 10% in accordance with the State Pharmacopoeia of the Union of Soviet Socialist Republics. However, this causes ambiguous results, impeding precise quality control. To improve ambiguous quality control criteria, this study developed a new HPLC method using two novel marker compounds (inotodiol and 3β-hydroxylanosta-8,24-dien-21-al) to control the quality control of I. obliquus . The HPLC analysis was carried out in a C18 column with an isocratic elution of 95% acetonitrile at 210 nm. The developed method validated in terms of linearity, precision, accuracy, and recovery. The content criteria were established by the linear regression method and relative standard deviation method. As the results of the quantitative monitoring, 1.165 mg/g of inotodiol and 1.717 mg/g of 3β-hydroxylanosta-8,24-dien-21-al, calculated by the relative standard deviation method, were suggested new quality criteria. A new HPLC method was developed to improve current quality control of I. obliquus and new lower content criteria were proposed as a result of quantitative monitoring. Graphical abstract

Quality control and evaluation of Inonotus obliquus using HPLC method with novel marker compounds