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目的建立通天口服液指纹图谱的超高效液相色谱(UPLC)分析方法。方法采用Agilent Zorbax SB-C_(18)色谱柱(100mm×2.1 mm,1.8μm),以乙腈(A)-0.05%磷酸溶液(B)为流动相,梯度洗脱(0~2.5 min、2.0%A,2.5~3 min、2.0%~9.0%A,3~7 min、9.0%~10.0%A,7~7.5 min、10%~14%A,7.5~17 min、14%~18.3%A,17~27 min、20%~95%A,27~32 min、95%A),流速0.4 m L·min~(-1),检测波长230 nm,柱温40℃。结果以芍药苷作为参照物峰,确定了通天口服液的指纹图谱,指定了20个共有峰,10批样品的相似度均大于0.95;20个特征峰的相对保留时间具有较好的重复性(RSD<1%)。结论所用方法快速、易操作、重复性好,可为提高通天口服液的质量标准提供参考。
Objective To establish a method for the analysis of the fingerprint of Tongtian oral liquid by ultra performance liquid chromatography (UPLC). Methods The mobile phase was eluted with acetonitrile (A) - 0.05% phosphoric acid solution (B) with gradient elution (0 ~ 2.5 min, 2.0%) on an Agilent Zorbax SB-C 18 column (100 mm × 2.1 mm, 1.8 μm) A, 2.5-3 min, 2.0-9.0% A, 3-7 min, 9.0-10.0% A, 7-7.5 min, 10-14% A, 7.5-17 min, 14-18.3% 17 ~ 27 min, 20% ~ 95% A, 27 ~ 32 min, 95% A) at a flow rate of 0.4 m L · min ~ Results With paeoniflorin as the reference peak, the fingerprint of Tongtian oral solution was determined, and 20 common peaks were assigned. The similarity of 10 batches of samples was greater than 0.95. The relative retention times of 20 characteristic peaks showed good reproducibility RSD <1%). Conclusion The method used is rapid, easy to operate and has good repeatability. It can provide reference for improving the quality standard of Tongtian Oral Liquid.