复方苦参注射液UPLC指纹图谱检测及6种成分含量测定

目的 建立复方苦参注射液的超高效液相色谱法(UPLC)指纹图谱,并同时测定其中6种指标成分的含量。方法 采用ACQUITY UPLC CSH^TM C₁₈(2.1 mm×100 mm,1.7 μm)色谱柱,以甲醇2 g·L^-1磷酸二氢钾为流动相梯度洗脱,流速0.3 mL·min^-1,柱温30℃,检测波长211 nm。结果 建立复方苦参注射液UPLC指纹图谱,确立了9个共有峰,10批样品相似度均大于0.99。甲基氧化偶氮甲醇樱草糖苷、苦参碱、槐果碱、槐定碱、氧化槐果碱、氧化苦参碱6种成分在相应浓度范围内与峰面积的线性关系良好,平均加样回收率分别为100.42%、100.90%、101.45%、103.85%、99.95%、100.46%,相对标准偏差(RSD)值分别为1.96%、0.67%、1.60%、1.15%、1.02%、1.20%。结论 本研究建立的复方苦参注射液的UPLC指纹图谱及多成分含量测定方法,操作简单,重复性好,稳定可靠,为复方苦参注射液的质量标准研究提供更加全面的依据。

Study on the UPLC Fingerprint and Determination of Six Components of Compound Kushen Injection

OBJECTIVE To establish the UPLC fingerprint of compound Kushen injection (CKI) and determine the contents of six index components simultaneously. METHODS Using ACQUITY UPLC CSH C₁₈ (2.1 mm×100 mm,1.7 μm) column, the mobile phase was methanol-2 g·L^-1 potassium dihydrogen phosphate, gradient elution was conducted at a flow rate of 0.3 mL·min^-1, column temperature was maintained at 30 ℃, detection wavelength was maintained at 211 nm. RESULTS The UPLC fingerprint of CKI was established, and nine common peaks were distinguished. The similarity of 10 batches of samples were all above 0.99. The calibration curves of macrozamin, matrine, sophocarpine, sophoridine, oxysophocarpine and oxymatrine showed good linear relationship within the corresponding concentration ranges. The average recovery rates were 100.42%, 100.90%, 101.45%, 103.85%, 99.95% and 100.46%, with RSDs of 1.96%, 0.67%, 1.60%, 1.15%, 1.02% and 1.20%, respectively. CONCLUSION The established method of UPLC fingerprint and multi-content determination method are simple, repeatable and reliable at the same time, which can provide comprehensive reference for the quality control of CKI.