论文部分内容阅读
目的对佛波双酯注射液的含量测定方法进行改进提高。方法采用HPLC法测定佛波双酯注射液的含量及有关物质,色谱柱由Kromasil KR100-5c18柱(250mm×4.6mm,5μm)改为Shimpack PA-DEAE柱(固定相为二乙氨乙基,规格20mm×10cm,10μm),流动相由:乙腈-甲醇-水(45:45:10)改为乙腈-甲醇-水(60:35:5),流速为:1ml/min^-1,检测波长为:232nm。结果改进后用HPLC法测定佛波双酯注射液中佛波双酯的含量,佛波双酯在浓度33.5～354.4μg/ml范围内,线性关系良好(r=0.99998);低、中、高3种浓度的方法回收率分别为100.8%、100.6%和100.9%,RSD均小于1.8%(n=3),平均回收率为100.8%,RSD为1.46。结论本实验方法较原来的含量测定方法更简便、准确,灵敏,线性范围有所提高,相关程度增大,RSD值较原方法更精确,可用于佛波双酯注射液的含量测定,能更有效控制产品质量。
Objective To improve and improve the method for the determination of the content of phorbol diester injection. Methods HPLC method was used to determine the content and the related substances of phorbol diester injection. The column was changed from Kromasil KR100-5c18 column (250mm × 4.6mm, 5μm) to Shimpack PA-DEAE column (the stationary phase was diethylaminoethyl, Size 20mm × 10cm, 10μm). The mobile phase was changed from acetonitrile-methanol-water (45:45:10) to acetonitrile-methanol-water Wavelength: 232nm. Results After the improvement, the content of phorbol diester in phorbol diester injection was determined by HPLC method. The phorbol diester showed good linearity (r = 0.99998) in the range of 33.5-354.4μg / ml; the low, middle and high The recoveries of the three concentrations were 100.8%, 100.6% and 100.9%, respectively. The RSDs were less than 1.8% (n = 3). The average recovery was 100.8% and the RSD was 1.46. Conclusion The experimental method is simple, accurate, sensitive and linear range is improved compared with the original method, the correlation degree is increased, the RSD value is more accurate than the original method, which can be used for the determination of the content of the PPB, Effective control of product quality.