草麻黄HPLC特征图谱研究

Study on HPLC Specific Chromatograms of Ephedra sinica Stapf.

目的建立草麻黄的HPLC特征图谱,为其质量标准的制定提供依据。方法采用RP-HPLC,色谱柱为Waters XBridgeTM Phenyl(250 mm×4.6 mm,5μm),以甲醇-0.092%磷酸(含0.04%三乙胺和0.02%二正丁胺)为流动相,梯度洗脱,0～14 min流速为0.8 mL/min,21～60 min流速为1.0 mL/min,检测波长210 nm,柱温30℃,进样体积为10μL,记录时间为60 min。结果 HPLC特征图谱的方法学考察结果符合要求,共标定草麻黄HPLC特征图谱的9个特征峰,指认其中盐酸麻黄碱、盐酸伪麻黄碱和盐酸甲基麻黄碱3个特征峰,10批草麻黄特征图谱的相似度为0.861～0.982。结论本研究建立的草麻黄HPLC特征图谱可为草麻黄质量标准的建立提供依据。

Objective To establish an HPLC specific chromatograms of Ephedra sinica Stapf. and to provide a basis for establishment of quality standards of Ephedra sinica Stapf. Methods The RP-HPLC method were adopted, with Waters XBridgeTM phenyl （250 mm × 4.6 mm, 5 μm） as the chromatographic column. Methanol and water containing 0.092% phosphoric acid, 0.04% triethylamine and 0.02% dibutylamine was as the mobile phase for gradient elution. Flow rate of 0–14 min was 0.8 mL/min; flow rate of 21–60 min was 1.0 mL/min. The detection wavelength was set at 210 nm. The column temperature was 30 ℃. The sample volume was 10 μL. The recording time was 60 min. Results The methodological study of HPLC specific chromatograms met relevant requirements. A total of nine characteristic peaks of HPLC specific chromatograms of Ephedra sinica Stapf. were marked, and three characteristic peaks of ephedrine hydrochloride, pseudoephedrine hydrochloride and methylephedrine hydrochloride were identified. Similarities of 10 batches of Ephedra sinica Stapf. were among 0.861–0.982. Conclusion The HPLC specific chromatograms of Ephedra sinica Stapf. can provide a basis for establishment of quality standards of Ephedra sinica Stapf.