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目的 :建立不同批次重连口服液UPLC指纹图谱测定方法。方法 :采用UPLC测定了10批重连口服液样品。色谱条件为Waters HSS T3 C18柱(50 mm×2.1 mm,1.8μm);流动相为乙腈(A)-0.05%磷酸水溶液(B),梯度洗脱;检测波长270 nm;流速0.25 mL·min-1;柱温30℃。结果 :建立了10批重连口服液UPLC指纹图谱,并进行了相似度比较,进一步对其中的射干苷、黄芩苷、连翘苷、黄芩素和汉黄芩素5个色谱峰进行了归属。结论 :该法操作简便、重复性好,可用于重连口服液的质量评价和质量控制。
Objective: To establish a method for determination of UPLC fingerprints of different batches of rehydration oral liquid. Methods: UPLC was used to determine 10 batches of oral rehydration samples. The chromatographic conditions were Waters HSS T3 C18 column (50 mm × 2.1 mm, 1.8 μm); the mobile phase consisted of acetonitrile-0.05% phosphoric acid solution (B) with gradient elution at a detection wavelength of 270 nm and a flow rate of 0.25 mL · min- 1; column temperature 30 ℃. Results: UPLC fingerprints of ten batches of recombinant Lianhe oral liquid were established and the similarity was compared. Five peaks of cantharidin, baicalin, forsythin, baicalein and wogonin were further assigned. Conclusion: The method is simple, reproducible, and can be used for the quality evaluation and quality control of rehydration oral liquid.