首页|小儿清热止咳口服液高效液相色谱指纹图谱的建立及8种成分含量测定

小儿清热止咳口服液高效液相色谱指纹图谱的建立及8种成分含量测定

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目的 建立小儿清热止咳口服液的高效液相色谱(HPLC)指纹图谱,并测定其中 8 种主要成分的含量。方法 色谱柱为Agilent Infinity Lab Poroshell 120 EC-C18 柱(150 mm×4。6 mm,2。7 μm),流动相为乙腈-甲醇(89∶11,V/V)-0。01mol/L磷酸二氢钾溶液(pH 3。2),梯度洗脱,流速为 1。0 mL/min,检测波长为 210 nm(0~31 min)、270 nm(31~75 min),柱温为 30℃,进样量为 10 μL。结果 共得到 28 个共有峰,其中 26 个可找到归属,各批样品间相似度均大于 0。99。盐酸麻黄碱、黄芩苷、苦杏仁苷、甘草酸铵、盐酸伪麻黄碱、黄芩素、甘草苷、(R,S)-告依春质量浓度分别在 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范围内与峰面积线性关系良好(r≥0。999 4),检测限为 0。068 6~0。857 6 μg/mL,定量限为 0。328 4~1。615 2 μg/mL;稳定性、重复性、中间精密度试验结果的RSD均小于 3。0%;平均加样回收率为 97。90%~101。44%,RSD为 0。45%~1。85%(n = 6)。结论 该方法灵敏、简便、准确,可用于小儿清热止咳口服液的质量控制。
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.

Xiaoer Qingre Zhike Oral LiquidHPLCfingerprintephedrine hydrochloridebaicalinamygdalincontent determination

潘燕、胡林水、吴明

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浙江康恩贝制药股份有限公司,浙江 金华 321109

浙江省中药制药技术重点实验室,浙江 金华 321109

小儿清热止咳口服液 高效液相色谱法 指纹图谱 盐酸麻黄碱 黄芩苷 苦杏仁苷 含量测定

2024

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
年,卷(期):2024.33(8)
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