HPLC测定苦参碱葡萄糖注射液中苦参碱含量、5-羟甲基糠醛及有关物质

Determination of Matrine,5-Hydroxymethylfurfural and Related Substances in Injection Containing Matrine and Glucose by HPLC

目的:建立测定苦参碱葡萄糖注射液中苦参碱含量、5-羟甲基糠醛及有关物质的方法.方法:采用HPLC,在以氨基硅烷键合硅胶为柱填充剂、乙腈-0.02mol/L磷酸二氢钠溶液(75∶25)为流动相、检测波长为210nm的条件下分3批样品进行测定,理论板数以苦参碱计≥5000.结果:苦参碱浓度在21.966Mg/m l^109.83μg/m l范围内与峰面积呈良好的线性关系,r=0.999 9,平均回收率为100.43%,RSD为2.02%(n=9),对有关物质与5-羟甲基糠醛的测定均取得满意结果.结论:本法准确、灵敏、重现性好,可以用于苦参碱葡萄糖注射液的质量控制.

Objecttive, to study the determination of matrine, 5 - hydroxymethyfurfural, and related substances in matrine and glucose injection. Methods： the high-performance liquid chromatography （HPLC） method was carried out according to the Chinese Pharmacopoeia, 3 batch of samples were determined under the condition： amino-bonded silica as the column, acetonitrile-0.02mol/L NaH2PO4 solution （75： 25） as the mobile phase, the detection wavelength was 210nm and the theoretical plates were more than 5000 calculated by matrine. Results, the calibration curve was linear in the range of 21. 966-- 109.83μg/ml （ r = 0.999 9）. The mean recovery was 100.43 %, RSD was 2.02 % （ n = 9）, the determination of 5-Hydroxymethylfurfural and related substances also have good results. Conclusion, this method is sensitive, accurate and reproducible, can be used for quality control of matrine and glucose Injection.