津力达颗粒UPLC指纹图谱

UPLC Fingerprints of Jinlida Granule

摘要:

目的: 采用超高效液相色谱(UPLC)法建立津力达颗粒的指纹图谱。 方法: 采用Waters ACQUITY UPLC BEH C₁₈ 色谱柱(2.1 mm×100 mm,1.7 μm),流动相乙腈-0.1%磷酸水,梯度洗脱,流速0.3 mL·min^-1,柱温40℃,检测波长203 nm。 结果: 建立了津力达颗粒的UPLC指纹图谱,共标定了50个共有峰,指认了其中9个共有峰,10批津力达颗粒指纹图谱的相似度均在0.991~1.000。 结论: 该方法具有良好的精密度、稳定性和重复性,可有效控制津力达颗粒质量。

Abstract:

Objective:To develop an ultra performance liquid chromatography (UPLC) method for fingerprints of Jinlida granule. Method: The Waters Acquity UPLC BEH C₁₈(2.1 mm×100 mm, 1.7 μm) column was used. Acetonitrile and water containing 0.1% phosphoric acid were used as mobile phase with gradient elution. The detection wavelength was set at 203 nm. Flow rate was set at 0.3 mL·min^-1 and column temperature was maintained at 40℃. Result: UPLC fingerprint was established with 50 common peaks, nine of 50 common peaks were identified, and the similar degrees of the UPLC fingerprints of Jinlida granule from 10 batches were between 0.991 and 1.000. Conclusion: The method of fingerprints has acceptable precision, reproducibility and stability, which can be used as a new means for the quality control of Jinlida granule.