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目的:比较《中国药典》法定方法与改进方法测定盐酸小檗碱片的含量。方法:色谱柱:Diamonsil~(TM)(钻石)C_(18)(200mm×4.6mm,5μm);柱温:35℃;流速:1.0ml·min~(-1);检测波长:263nm;进样量:20μl;药典方法流动相:磷酸盐缓冲液[0.05mol·L~(-1)磷酸二氢钾和0.05mol·L~(-1)庚烷磺酸钠(1:1),含0.2%三乙胺,并用磷酸调节pH至3.0]-乙腈(60:40);溶剂:沸水;改进方法流动相:乙腈-0.05%十二烷基硫酸钠(含1%的磷酸)(48:52);样品溶剂:甲醇。结果:改进方法中盐酸小檗碱的线性范围为10.0～200.0μg·ml~(-1)(r=0.999 9);平均回收率为98.8%,RSD为0.4%。两种含量测定方法的结果基本一致。结论:改进方法快速、简便易行、结果准确。
Objective: To compare the Chinese Pharmacopoeia statutory methods and improved methods for the determination of berberine hydrochloride tablets. Method: Column: Diamonsil ~ (diamond) C 18 (200mm × 4.6mm, 5μm); column temperature 35 ℃; flow rate 1.0ml · min -1; detection wavelength 263nm; Sample volume: 20μl; Pharmacopoeia Mobile phase: Phosphate buffer [0.05mol·L -1 potassium dihydrogen phosphate and 0.05mol·L -1 sodium heptane sulfonate (1: 1) 0.2% Triethylamine and adjusted to pH 3.0 with phosphoric acid - Acetonitrile (60:40); Solvent: Boiling water; Improved method Mobile phase: Acetonitrile- 0.05% Sodium lauryl sulfate with 1% phosphoric acid (48: 52); sample solvent: methanol. Results: The linear range of berberine hydrochloride was 10.0 ~ 200.0μg · ml -1 (r = 0.999 9). The average recovery was 98.8% and the RSD was 0.4%. The results of the two methods of determination are basically the same. Conclusion: The improvement method is quick, simple and easy, and the result is accurate.