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AIM To establish the UPLC fingerprints of Gegen Qinlian Pills (Puerariae lobatae Radix,Scutellariae Radix,Coptidis Rhizoma and Glycyrrhizae Radix et Rhizoma Praeparata cum Melle) and to determine the contents of puerarin,baicalein,palmatine,wogonin,daidzin,daidzein and jateorhizine.METHODS The analysis of 70％ methanol extract of this drug was performed on a 30 ℃ thermostatic Waters ACQUITY UPLC(C) BEH C18column,with the mobile phase comprising of methanol-0.1％ glacial acetic acid flowing at 0.3 mL/min in a gradient manner,and the detection wavelength was set at 260 nm.RESULTS There were twenty-five common peaks in the fingerprints of ten batches of samples with the similarities of more than 0.98.Seven constituents showed good linear relationships within their own ranges (r ＞ 0.999 0),whose average recoveries were 98.99％-103.6％ with the RSDs of 1.13％-2.03％.CONCLUSION This simple,reliable and reproducible method can be used for the quality control of Gegen Qinlian Pills.
RESUMEN
Objective To develop a quantitative analysis multi-components by single marker (QAMS) method for the quantification of multiple characteristic components, namely, puerarin, daidzin, jatrorrhizine, palmatine, soybean glycol, wogonoside, wogonin, in Gegen Qinlian Pills (GQP) with puerarin as the internal reference. Methods Samples were analyzed by Waters ultra-high efficiency liquid chromatography (UPLC) system, equipped with a reverse phase Acquity BEH C18 chromatographic column, with the mobile phase of methanol-0.1% phosphoric acid solution at a flow rate of 0.3 mL/min. The column temperature and the detection wavelength set at 30 ℃ and 260 nm respectively. Based on puerarin as the internal reference, the relative correction factors (RCFs) with other six characteristic components were calculated, then compared with the external standard method. This result benefits to verify the accuracy and advantages of the established QAMS method. Results Under the linear range of determination, RCFs of daidzin, jatrorrhizine, palmatine, soybean glycol, wogonoside, wogonin with reference to puerarin, were 1.02, 1.07, 1.05, 1.32, 0.62, and 0.90 in GQP, respectively. And the repeatability was good in different experimental conditions. Moreover, there was no significant difference on the quantitative results of seven characteristic components, derived from between external standard method and QAMS method in the 10 batches of GQP samples. The range of seven characteristic components contents in the 10 batches of GQP samples, namely puerarin, daidzin, jatrorrhizine, palmatine, soybean glycol, wogonoside and wogonin, were 8.923-10.746 mg/g, 2.231-2.988 mg/g, 0.825-1.197 mg/g, 1.274-1.522 mg/g, 2.330-2.713 mg/g, 0.836-0.951 mg/g, and 0.901-1.092 mg/g, respectively. Conclusion In present study, a feasible, convenient and accurate QAMS method with puerarin as the internal reference was established. Therefore, it is suitable to quantify multiple characteristic components in GQP and provide a useful approach for the quality control of GQP.