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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 study the HPLC profile of citron formula particles and provide a reliable method for its quality control. Methods: The HPLC method was adopted. The column was Luna-C18 (5μm × 4.6 mm × 250 mm) with gradient elution with acetonitrile-1% glacial acetic acid as the mobile phase. The column temperature was 30 ℃ and the flow rate was 1.0 m L / min, the detection wavelength is 320 nm. Results: High performance liquid chromatography (HPLC) profiles of citron formulations were initially established and six characteristic peaks were identified. The batch of Citron formula particles for validation, good repeatability, the peak time is more stable. Conclusion: HPLC profiling provides a stable and reliable new method for the quality control of citron formulations.