HPLC法同时测定克咳胶囊中4种生物碱的含量

Simultaneous Determination of Four Alkaloids in KeKe Capsules by HPLC

目的建立HPLC法同时测定克咳胶囊中4种生物碱成分(盐酸麻黄碱、盐酸伪麻黄碱、吗啡、磷酸可待因)的含量。方法C_(18)色谱柱(Aglient,ZOBRAX XDB,250 mm×4.6 mm,5μm),以乙腈-0.1%磷酸溶液(含0.1%三乙胺)为流动相,梯度洗脱,流速1.0 mL·min^(-1),柱温30℃,检测波长210 nm。结果盐酸麻黄碱、盐酸伪麻黄碱、吗啡、磷酸可待因的线性范围分别为0.0197~0.3942 mg·mL^(-1)(r=0.9999)、0.0119~0.2390 mg·mL^(-1)(r=0.9999),0.0099~0.1988 mg·mL^(-1)(r=0.9997),0.0023~0.0452 mg·mL^(-1)(r=0.9990)。加样回收率为97.34%~98.53%(n=6),RSD均低于2.5%。精密度、稳定性、重复性的RSD均低于2.0%。结论该方法操作简便快捷,重复性好,可用于克咳胶囊的质量控制。

OBJECTIVE To establish an HPLC method for simultaneous determination of four alkaloids(ephedrine hydrochloride,pseudoephedrine hydrochloride,morphine and codeine phosphate)in KeKe tablets.METHODS Agilent ZOBRAX XDB-C_(18) column(250 mm×4.6 mm,5μm).Acetonitrile-0.1%phosphoric acid solution(containing 0.1%triethylamine)with gradient elution at a flow rate of 1.0 mL·min^(-1),the column temperature was 30℃,the wavelength of detection was set at 210 nm.RESULTS The standard curves of ephedrine hydrochloride,pseudoephedrine hydrochloride,morphine and codeine phosphate were linear over the ranges of 0.0197-0.3942 mg·mL^(-1)(r=0.9999)、0.0119-0.2390 mg·mL^(-1)(r=0.9999),0.0099-0.1988 mg·mL^(-1)(r=0.9997),0.0023-0.0452 mg·mL^(-1)(r=0.9990)。The average recoveries were between 97.34-98.53%(n=6)with RSDs all less than 2.5%.The RSDs of the precision,reproducibility and stability tests were all less than 2.0%.CONCLUSION This method is simple,accurate,repeatable and can be used for quality control of the KeKe Capsules.