基于超高效液相色谱指纹图谱和多成分含量测定的黄芪益肾颗粒质量评价

目的:建立黄芪益肾颗粒超高效液相色谱(UPLC)指纹图谱及多成分含量测定方法,并进行化学计量学分析,为其质量控制提供依据.方法:采用Waters CORTECS UPLC T3色谱柱(2.1mm×150 mm,1.6μm),柱温30℃;流动相为乙腈-0.1％冰醋酸,梯度洗脱,体积流量为0.25 mL· min-1;检测...

Quality evaluation of astragalus membranaceus kidney particles based on UPLC fingerprint and multi-component content determination

OBJECTIVE To establish the UPLC fingerprint and multi-component content determination method with stoichiometric analysis for astragalus membranaceus kidney particles to provide basis for its quality control.METHODS The chromatographic column was Waters CORTECS UPLC T3(2.1 mm×150 mm, 1.6 μm), and the column temperature was set at 30 ℃. The mobile phase was composed of acetonitrile-0.1% glacial acetic acid in gradient elution mode at a flow rate of 0.25 mL·min^-1. And the detection wavelength was 270 nm. The UPLC fingerprint of astragalus membranaceus kidney particles was established by using Chromatographic Fingerprint Similarity Evaluation System of TCM(2012 edition). And the quality of 11 batches of astragalus membranaceus kidney particles was evaluated. The content determination methods for icariin, epmedin A1, epmedin B, epmedin C, baohuoside I, calycosin-7-O-β-D-glucopyranoside and rhein were verified by methodology.RESULTS The UPLC fingerprint of astragalus membranaceus kidney particles confirmed 17 common peaks, and among them, 7 common peaks were identified and their content determination methods were established. The similarity of 11 batches of samples of astragalus membranaceus kidney particles was all more than 0.95. Seven components had good linear relationships within the ranges of mass concentration(R²≥0.999 6). The average recoveries were 98.67%-100.06% with the RSDs of 1.4%-2.1%.CONCLUSION The method is simple and efficient, which can be used for the quality control of the preparation.