摘要
目的:研究香橼配方颗粒的高效液相特征图谱,为其质量控制提供可靠的方法。方法:采用HPLC法,色谱柱为Luna-C18(5μm×4.6 mm×250 mm),以乙腈-1%冰醋酸溶液为流动相进行梯度洗脱,柱温为30℃,流速为1.0 m L/min,检测波长为320 nm。结果:初步建立了香橼配方颗粒的高效液相特征图谱,共确定出6个特征峰。对各批香橼配方颗粒进行验证,重复性好,出峰时间较为稳定。结论:高效液相特征图谱为香橼配方颗粒的质量控制提供了一种稳定、可靠的新方法。
Objective: To establish the HPLC characteristic chromatogram of Citron Dispensing Granules to providethe reliable method for its quality control. Methods: The chromatograms were obtained using the Luna-C18column(250 mm×4.6 mm,5 μm). The mobile phase comprising of acetonitrile-1% glacial acetic acid aqueous solution was used for gradient elution.The column temperature was 30 ℃. The flow rate and detection wavelength were set at 1.0 m L/min and 320 nm respectively. Results: The HPLC characteristic chromatogram of Citron Dispensing Granules was preliminarily established and 6 main marker peaks were selected in the standard characteristic chromatogram. Citron Dispensing Granule for each batch particles were verified, reproducible, peak time more stable. Conclusion: The HPLC characteristic chromatogram may provide a new, stable and reliable method for controlling the quality of Citron Dispensing Granules.
引文
[1]国家药典委员会.中国药典[M].北京:中国医药科技出版社,2015:258-259.
[2]毛淑杰,朱景宁,顾雪竹,等.香橼药材高效液相指纹图谱研究[J].中药材,2007,30(8):932-936.
