Dissolution of Yinxingye Dispersible Tablets by Quantitative Analysis of Multi-components with Single-marker / 中国药师

ABSTRACT

Objective:To establish a quantitative analysis method for determining the dissolution of Yinxingye dispersible tablets by quantitative analysis of multi-components with single-marker ( QAMS) . Methods:A small glass method was adopted. Hydrochloric acid (0. 1 mol·L-1 ) was used as the dissolution medium, and the stirring speed was at 50 r·min-1 . HPLC-ELSD with gradient elu-tion combined with QAMS was used to simultaneously determine the dissolution of 3 total flavonoids ( artemisinin, quercetin and isorh-amnetin) and 4 total lactones (ginkgo esters and lactones a, b and c) in Yinxingye dispersible tablets. Results:Within a certain line-ar range, the relative correction factors (RCFs) of quercetin and isorhamnetin with the reference of artemisinin was 1. 873 and 0. 324, respectively, and the RCFs of lactones a, b and c with the reference of ginkgo esters was 2. 280, 1. 659 and 1. 429, respectively, and the repeatability was good under the different experimental conditions. There were no significant differences between the calculated val-ues by QAMS and those by the external standard method in 5 batches of Yinxingye dispersible tablets, and the results showed that the RCFs was authentic. The dissolution uniformity of Yinxingye dispersible tablets was good in 0. 1 mol·L-1 hydrochloric acid. Conclu-sionThe method is simple, accurate and reproducible in the dissolution determination of Yinxingye dispersible tablets.