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目的:建立龙加通络胶囊的HPLC和UPLC特征指纹图谱分析方法,比较UPLC与HPLC分析龙加通络胶囊指纹图谱的效果,为快速评价龙加通络胶囊的质量,完善其质量控制方法提供依据。方法:UPLC色谱系统采用Agilent Poroshell120 Bonus-RP色谱柱(3.0 mm×50 mm,2.7μm),流动相乙腈-水溶液,梯度洗脱,检测波长203 nm,柱温25℃;HPLC色谱系统采用Agilent Zorbox ODS色谱柱(4.6 mm×250 mm,5μm),流动相乙腈-水溶液,梯度洗脱,检测波长203 nm,柱温35℃;并分别采用UPLC与HPLC对10批龙加通络胶囊进行指纹图谱分析。结果:分别建立了龙加通络胶囊的UPLC与HPLC指纹图谱共有模式。以薯蓣皂苷为参照峰,其中UPLC标识出17个共有峰,HPLC标识出13个共有峰,10批样品的相似度均>0.9。结论:2种方法均可用于龙加通络胶囊质量控制,分离效果好、稳定性高、重复性好,UPLC较HPLC更高效、快速、灵敏。
OBJECTIVE: To establish HPLC and UPLC fingerprinting methods for the determination of Longjia Tongliao capsule and to compare the results of UPLC and HPLC for the fingerprint analysis of Longjia Tongluo capsule. To provide a quick assessment of the quality of Longjia Tongluo capsule and its quality control methods in accordance with. Methods: UPLC was performed on an Agilent Poroshell 120 Bonus-RP column (3.0 mm × 50 mm, 2.7 μm) using a mobile phase of acetonitrile-water with a gradient of 203 nm at a detection wavelength of 25 ° C. The HPLC system was equipped with an Agilent Zorbox ODS column (4.6 mm × 250 mm, 5 μm), mobile phase of acetonitrile-water, gradient elution, detection wavelength of 203 nm and column temperature of 35 ℃. Fingerprinting analysis. Results: The common mode of UPLC and HPLC fingerprinting were established respectively. Using dioscin as the reference peak, 17 common peaks were identified by UPLC, and 13 common peaks were identified by HPLC. The similarity of the ten batches of samples was> 0.9. Conclusion: The two methods can be used for the quality control of Long Jiatongluo Capsules. The separation effect is good, the stability is high and the repeatability is good. UPLC is more efficient, rapid and sensitive than HPLC.