HPLC法同时测定芩连片中盐酸巴马汀和盐酸小檗碱的含量

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

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（4．6mm×200mm，5μm）。流动相为50mmol·L^-1磷酸二氢钠（pH4．6）-乙腈（体积比72：28），流速为1．0mL·min^-1，检测波长为343nm，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5．2～52．0mg·L^-1（r=0．9998）内、盐酸小檗碱的质量浓度在30．4～304．0mg·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。

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 NaHEPO4 （pH 4.6） and acetonitrile at the rate of V： V = 72：28, The column temperature was set at 35 ℃ 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 × 10^4ρ ＋ 7. 369 × 10^2（ 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 × 10^4ρ ＋ 8,978 × 10^3（ 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, Conclusions The method can be used in the quality control of Qinlian tablets.