中国执业药师Issue(2)：21-24,4.DOI:10.3969/j.issn.1672-5433.2016.02.005
复方左炔诺孕酮片溶出度测定方法研究
Research on Determination Method for Dissolution of Compound Levonorgestrel Tablets
胡楚楚 1郑国钢1
作者信息
- 1. 浙江省食品药品检验研究院，浙江 杭州310052
- 折叠
摘要
Abstract
ABSTRACTObjective:To develop a method for determination of the dissolution of compound levonorgestrel tablets.Methods:The 0.1 mol/L hydrochloric acid solution containing 0.1% sodium dodecyl sulfate was used as a solvent, and the paddle was rotated at a rate of 75 r/min for 30 min, afterwards samples were taken and determined by HPLC using C18 colume(4.6 mm×250 mm, 5μm)as a stationary phase and acetonitrile-water (60∶40)as a mobile phase. The flow rate was 1.0 mL/min. An ultraviolet spectrophotometer set at a wavelength of 247 nm was used for levonorgestrel analysis, and a spectrofluorometric detector was used for ethinylestradiol analysis at an excitation wavelength of 285 nm and an emission wavelength of 310 nm.Results:The linear ranges of levonorgestrel and ethinylestradiol concentrations were 0.059 88~0.359 3 and 0.012 19 ~0.073 15μg/mL, while the average recovery rates were 99.2% and 99.0%, respectively.Conclusion:A novel method for determination of dissolution of compound levonorgestrel tablets was developed, which was reproducible, stable and reliable, and might be used for quality control of drugs.关键词
高效液相色谱法/复方左炔诺孕酮片/溶出度Key words
HPLC/Compound Levonorgestrel Tablets/Dissolution引用本文复制引用
胡楚楚,郑国钢..复方左炔诺孕酮片溶出度测定方法研究[J].中国执业药师,2016,(2):21-24,4.
