UPLC法测定补肾强身胶囊的5种活性成分及其指纹图谱分析  

Determination of five active components of Bushen Qiangshen capsule by UPLC and it’s fingerprint study

作　　者：车爽 周军 关鑫[2] CHE Shuang;ZHOU Jun;GUAN Xin(Tianjin Institute for Drug Control,Tianjin,300000 P.R.China;Tianjin Nankai Hospital,Tianjin,300000 P.R.China)

机构地区：[1]天津市药品检验研究院,天津300000 [2]天津市南开医院,天津300000

出　　处：《华西药学杂志》2021年第5期539-543,共5页West China Journal of Pharmaceutical Sciences

摘　　要：目的测定补肾强身胶囊的UPLC指纹图谱和淫羊藿苷、朝藿定A、朝藿定B、朝藿定C、特女贞苷等的含量。结合指纹图谱和含量测定结果,为评价补肾强身胶囊的质量提供依据。方法采用Acquity UPLC HSS T3色谱柱(100 mm×2.1 mm, 1.8μm),流动相为乙腈-0.1%磷酸水溶液体系,梯度洗脱,流速0.3 mL·min^(-1),检测波长220 nm,柱温35℃。结果得到分离度和重复性良好的补肾强身胶囊的UPLC指纹图谱,来自同一企业10批样品的相似度大于0.98,标示出19个共有峰,并对来自15家不同企业的样品进行了相似度的计算,结果差异较大。5个活性成分在一定范围内呈现良好的线性,r^(2)>0.9990;精密度和重复性良好(RSD<2.00%),在24 h内稳定性良好(RSD<2.00%),加样回收率为99.44%~100.38%(RSD<2.0%)。结论所用方法简便、快捷、准确,可作为有效评价该制剂质量的方法。OBJECTIVE To determine a UPLC fingerprint and five active compounds(icariin, epimedin A,epimedin B,epimedin C and specnuezhenide) of Bushen qiangshen capsule(BQC),combined with fingerprint and quantitative result to provide avidence for the evaluation of BQC.METHODS The fingerprinting analysis and the determination of five compounds were performed on the reversed-phase column of Acquity UPLC HSS T3(100 mm×2.1 mm, 1.8 μm),using acetonitrile-0.1% H_(3)PO_(4) with a flow rate of 0.3 mL·min^(-1) as mobile phase.The detective wavelength was set at 220 nm and the column temperature was 35 ℃.RESULTS The fingerprint chromatography with good resolution and reproducibility included 19 common peaks, and the similarity was more than 0.98 in the 10 batches of samples from the same manufacturer.The similarity of samples from 15 different manufacturers showed obvious differences.The calibration curve had a good linear relationship(r^(2)>0.9990).The RSD of precision and repeatability was less than 2.0%,and the stability was also good within 24 h(RSD<2.00%).The average recovery of these five compounds was between 99.44%-100.38%(RSD<2.00%).CONCLUSION A rapid, simple and accurate UPLC method is established for fingerprint and five components determination of BQC.Combined with the fingerprint and determination results, the method can be used for the quality control of BQC.

关 键 词：超高效液相色谱法 指纹图谱 补肾强身胶囊 含量测定 淫羊藿苷 朝藿定A 朝藿定B 朝藿定C 特女贞苷 

分 类 号：R917[医药卫生—药物分析学]