HPLC法同时测定芩连片中盐酸巴马汀和盐酸小檗碱的含量

目的建立同时测定芩连片中盐酸巴马汀和盐酸小檗碱含量的方法,用于芩连片的质量控制。方法采用HPLC法。色谱柱为Diamonsil ODS柱(4.6 mm×200 mm,5μm),流动相为50 mmol.L-1磷酸二氢钠(pH 4.6)-乙腈(体积比72∶28),流速为1.0 mL.min-1,检测波长为343 nm,柱温为35℃。结果芩连片中盐酸巴马汀、盐酸小檗碱与其他成分分离良好;盐酸巴马汀的质量浓度在5.2~52.0 mg.L-1(r=0.9998)内、盐酸小檗碱的质量浓度在30.4~304.0 mg.L-1(r=0.9997)内与峰面积呈良好的线性关系;盐酸巴马汀、盐酸小檗碱的回收率分别为100.1%、99.9%,RSD分别为1.1%、0.80%。结论所建立的同时测定芩连片中盐酸巴马汀和盐酸小檗碱含量的HPLC法准确、重现性好,可用于芩连片的质量控制。

Determination of palmatine hydrochloride and berberine hydrochloride in traditional Chinese patent medicine Qinlian tablets by HPLC

Abstract: Objective To establish an HPLC method for simultaneous determination of palmatine hydrochloride and berberine hydrochloride in Qinlian tablets. Methods The separation was performed on a Diamonsil C18（4.6 mm × 200 mm,5 μm）column. The mobile phase was composed of 50 mmol·L-1 NaH2PO4 ( pH 4.6 ) and acetonitrile at the rate of V:V=72:28. The column temperature was set at 35 °C and the flow rate was 1.0 mL·min-1 , with UV detection at 343 nm. Results The numbers of theoretical plates calculated by palmatine hydrochloride and berberine hydrochloride were 4 000 and 6 500, respectively. The regression equation of palmatine hydrochloride was A = 3.706 × 104ρ+ 7.369 × 102（r = 0.999 8）,which was linear over the ranger of 5.2-52.0 mg﹒L-1. The regression equation of berberine hydrochloride was A = 3.377 × 104ρ+ 8.978 × 103（r = 0.999 7）, which was linear over the ranger of 30.4-304.0 mg﹒L-1 .The average recovery was 100.1 % (RSD=1.1 %) for palmatine hydrochloride, 99.9% (RSD=0.80 %) for berberine hydrochloride. Conclusion The method can be used in the quality control of Qinlian tablets.