HPLC法测定复方小檗碱鞣酸蛋白胶囊中盐酸小檗碱的溶出度

Dissolution determination of Berberine Hydrochloride in Compound Berberine Hydrochloride Tannalbin Capsules by HPLC

目的:建立测定复方小檗碱鞣酸蛋白胶囊中盐酸小檗碱溶出度的方法。方法:采用高效液相色谱法,用十八烷基硅烷键合硅胶为填充剂;以磷酸盐缓冲液[0.05 mol·L^-1磷酸二氢钾溶液和0.05 mol·L^-1庚烷磺酸钠溶液(1∶1),含0.2%三乙胺,并用磷酸调节pH值至3.0]-甲醇(43∶57)为流动相;检测波长为262 nm,进样量为10μL。以醋酸盐缓冲液(pH4.0)1000 mL为溶出介质,转速为150 r·min^-1,取样时间为45 min,温度为37℃。结果:盐酸小檗碱在30.312 5~303.124 9μg·mL^-1范围内呈良好的线性关系(r=1),回收率为99.36%(n=9,RSD=0.98%)。结论:本法操作简便,准确、可靠,可用于复方小檗碱鞣酸蛋白胶囊中盐酸小檗碱溶出度的测定。

Objective To develop the method for the dissolution determination of berberine hydrochloride in Compound Berberine Hydrochloride Tannalbin Capsules. Methods HPLC method was used. Using octadecyl silane bonded silica as filler of chromatographic column, The mobile phase was made up of phosphate buffer [0.05 mol·L-1 potassium phosphate monobasic solution and 0.05 mol·L-1 sodium heptane-1-sulphonate solution(1∶1), containing 0.2% triethylamine and adjusting pH value to 3.0 with phosphoric acid]-methanol(43∶57),the detection wavelength was 262 nm,and the volume of injection was 10 μL·1000 mL of Acetate buffer(pH 4.0) was used as solvent. The rotation speed was 150 r·min-1,the sampling time was 45 min and the temperature was 37 ℃.Results Good linearity was shown for Berberine Hydrochloride in the concentration range of 30.312 5~303.124 9 μg·mL-1(r=1), The average recovery rate was 99.36%(n=9,RSD=0.98%).Conclusion The method is simple, accurate and reliable, and can be used to determination of the dissolution of berberine hydrochloride in Compound Berberine Hydrochloride Tannalbin Capsules.