Simultaneous Determination of Seven Components in Puyuan Hewei Capsules by QAMS
Objective To establish a quantitative analysis of multi-components by single marker(QAMS)method for the simultaneous determination of tetrahydropalmatine,palmatine hydrochloride,α-cyperone,caffeic acid,luteolin,liquiritin and ammonium glycyrrhizinate in Puyuan Hewei Capsules.Methods High-performance liquid chromatography(HPLC)method was adopted,the chromatographic column was Diamonsil C18 column(250 mm×4.6 mm,5 μm),the mobile phase was acetonitrile-0.1%phosphoric acid solution(gradient elution),the flow rate was 1.0 mL/min,the column temperature was 30℃,the detection wavelength was 237 nm,and the injection volume was 10 μL.With luteolin as the internal reference standard,the relative correction factors of tetrahydropalmatine,palmatine hydrochloride,α-cyperone,caffeic acid,liquiritin and ammonium glycyrrhizinate were established.The contents of seven components were determined by the methods of QAMS and external standard method(ESM),and the differences between the calculated values and the determined values were compared.Results The linear ranges of tetrahydropalmatine,palmatine hydrochloride,α-cyperone,caffeic acid,luteolin,liquiritin and ammonium glycyrrhizinate were 2.67-133.41 μg/mL,0.89-44.60 μg/mL,1.36-67.85 μg/mL,1.53-76.65 μg/mL,2.00-100.12 μg/mL,3.00-150.20 μg/mL,8.51-425.61 μg/mL(r≥0.999 5,n = 6).The RSDs of precision,stability,and repeatability test results were all lower than 2.0%(n = 6).The average recoveries of the above seven components were 99.09%,97.34%,97.42%,96.85%,98.60%,99.20%,and 99.09%,with RSDs of 0.72%,1.68%,1.75%,1.29%,0.69%,0.79%,and 0.97%(n = 9),respectively.The relative correction factors of the above seven components were 1.315 9,0.705 9,1.180 5,1.224 1,1.238 5,and 6.717 8,respectively.Good repeatability was observed in different chromatography columns,chromatographs,flow rates,and column temperatures,and the RSDs of the results were lower than 1.50%.The absolute value of the relative errors between the content determined by the QAMS method and the content calculated by the ESM was lower than 2.0%.Conclusion This method is reproducible,accurate and reliable,which can be used for the quality control of Puyuan Hewei Capsules.
万方数据
维普
