摘要
Abstract
Objective To establish a method for determination of phillyrin in Rutong′an Oral Solution and to develop a new quality standard. Methods An RP - HPLC method was adopted for the determination of phillyrin in Rutong′an Oral Solution. The HPLC conditions were as follows:Diamonsil C18(4. 6 mm × 150 mm,5 μm)column was used with column temperature 25 ℃;A mixture of acetonitrile - H2 O(25:75)served as mobile phase with flow rate 1. 0 mL·min - 1 ;The in-jection volume was 10 μL;The detection wavelength was 277 nm;The data acquisition time was 20 min and the theoretical plate number of phillyrin was over 3 000. Results The phillyrin showed a good linearity in the range of 0. 625 ~ 10. 00μg·mL - 1(r = 1. 000 0). The stability for samples extracted from Rutong′an Oral Solution,as well as the specialization,re-producibility,precision and recovery for the established quantitative method were in line with the requirements. The contents of phillyrin in the 3 batches of Rutong′ an Oral Solution samples were 14. 78,15. 31,15. 40 μg · mL - 1 ,respective-ly. Conclusion The established method was simple,stable with strong specificity and good repeatability,and can be ap-plied for quality control of Rutong′an Oral Solution.关键词
乳痛安口服液/连翘苷/高效液相色谱法/含量测定/质量标准Key words
Rutong′an Oral Solution/Phillyrin/HPLC/Determination/Quality standard分类
医药卫生
