A novel UPLC-MS/MS method for simultaneous determination of ten effective constituents in the Jixingshizhen(JXSZ ) preparation

A novel, reliable and reproducible UPLC-MS/MS method was developed and validated to simultaneously determine the ten bioactive constituents (baicalin, baicalein, wogonoside, wogonin, luteoloside, dictamnine, fraxinellone, obacunone, geniposidic acid, and glycyrrhizic acid) in Jixingshizhen(JXSZ) preparation. Compendiously, chromatographic separation was achieved on a Waters BEH C18 column with gradient elution employing a mobile phase composed of acetonitrile and 0.1% formic acid at a flow rate of 0.3 mL/min. All the analytes containing IS (verapamil) were detected without interference in the multiple-reaction monitoring (MRM) mode with positive electrospray ionization. Further, a comprehensive validation of the method was rigorously executed according to the guidelines of the International Conference on Harmonization (ICH) and Chinese Pharmacopoeia (2015 Edition). The results indicated that the validated method afforded desired linearity, precision, accuracy, sensitivity and stability. At length, the newly established method was successfully applied to quantify the ten effective ingredients in Jixingshizhen(JXSZ) granules from different production batches, indicating the proposed method in this paper was particularly preferable for the routine analysis of JXSZ preparation as well as the quality control, especially in situations where high sample throughput and fast analytical speed are required.