Establishment of HPLC Fingerprint and Determination of Eight Components in Xiaoer Qingre Zhike Oral Liquid
Objective To establish a high-performance liquid chromatography(HPLC)fingerprint of Xiaoer Qingre Zhike Oral Liquid,and to determine the contents of eight main components.Methods The chromatographic column was Agilent Infinity Lab Poroshell 120 EC-C18 column(150 mm×4.6 mm,2.7 μm),the mobile phase was acetonitrile-methanol(89∶11,V/V)-0.01 mol/L potassium dihydrogen phosphate solution(pH 3.2),with gradient elution,the flow rate was 1.0 mL/min,the detection wavelengths were 210 nm(0-31 min)and 270 nm(31-75 min),the column temperature was 30℃,and the injection volume was 10 μL.Results A total of 28 common peaks were obtained,of which 26 could be attributed specific medicinal herb,and the similarity of different batches of samples was greater than 0.99.The linear ranges of ephedrine hydrochloride,baicalin,amygdalin,ammonium glycyrrhizinate,pseudoephedrine hydrochloride,baicalein,liquiritin and(R,S)-epigoitrin were 2.05-41.06 μg/mL,38.42-768.48 μg/mL,9.00-179.93 μg/mL,3.23-64.61 μg/mL,1.09-21.90 μg/mL,1.49-29.80 μg/mL,1.94-38.87 μg/mL,0.69-13.71 μg/mL(r≥0.999 4)respectively.The limit of detection(LOD)and the limit of quantification(LOQ)were in the range of 0.068 6 to 0.857 6 μg/mL,0.328 4 to 1.615 2 μg/mL respectively.The RSDs of stability,repeatability and intermediate precision tests were all lower than 3.0%.The average recovery rate of the above eight components was in the range of 97.90%to 101.44%,with the RSD in the range of 0.45%to 1.85%(n = 6).Conclusion This method is sensitive,simple and accurate,which can be used for the quality control of Xiaoer Qingre Zhike Oral Liquid.