高效液相色谱法测定复方石栗喷雾剂中盐酸小檗碱含量

摘要

目的 建立测定复方石栗喷雾剂中盐酸小檗碱含量的高效液相色谱(HPLC)法.方法 色谱柱采用Zorbax300 SB-C18柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸溶液(50:50,每100 mL加十二烷基磺酸钠0.1 g),检测波长为265 nm,流速为1.0 mL/min,柱温为30℃.结果 盐酸小檗碱质量浓度在6.4~64.0μg/mL范围内与峰面积线性关系良好(r=0.9998),平均回收率为98.01%,RSD为1.63%(n=9).结论 该方法测定结果准确、稳定,重复性好,简便易行,可用于该制剂中盐酸小檗碱的含量测定.%Objective To establish an HPLC method to determine the content of berberine hydrochliride in Compound Shili Spray. Methods The determination was performed by HPLC using ZORBAX300SB-C18 column ( 250 mm × 4. 6 mm, 5 μm );the column tem-perature was 30 ℃, the mobile phase consisted of acelonitrile-0. 1% phosphoric acid solution ( 50:50 ) ( 0. 1 g sodium dodecylsulphate per 100 mL ) , the UV detection wavelength was 265 nm and the flow rate was 1. 0 mL/min. Results The berberine hydrochloride was in good linearity in the range of 6. 4-64. 0 μg/mL ( r=0. 9998 ) . The average recovery rate was 98. 01%, RSD=1. 63% ( n=9 ) . Conclusion The method is sensitive, accurate and reproducible, which can be used to control the content of berberine hydrochloride in Compound Shili Spray.