工业微生物2025，Vol.55Issue(3)：19-22,4.DOI:10.3969/j.issn.1001-6678.2025.03.007
HPLC法测定丙戊酰胺片的含量及溶出度的研究
Study on the Determination of Content and Dissolution of Valpromide Tablets by HPLC Method
摘要
Abstract
The article established a high-performance liquid chromatography(HPLC)method for determining the content of Valpromide Tablets,and improved its quality control standards through a newly developed method for determining the dissolution rate of Valpromide Tablets.The HPLC method was as followed.An Agilent ZORBAX Cig column(250 mm × 4.6 mm,5 μm)was used,with methanol-water(55∶45,V∶V)as the mobile phase and a detection wavelength of 205 nm.Dissolution determination method was as follows.According to the dissolution and release determination method(Appendix 0931,Part Ⅳ,Chinese Pharmacopoeia 2020 Edition,Method 1),500 mL of water was used as the dissolution medium,and the sample was taken at a rotation speed of 50 r/min for 45 minutes.The concentration of valpromide in the dissolution solution was determined by HPLC method.The linear range was 0.162 2-0.649 1 mg/mL(r=1.000).The average recovery was 100.83％with SRSD of 0.8％(n=9).This method is simple,accurate,and highly specific,which can effectively control the quality of Valpromide Tablets.关键词
丙戊酰胺片/高效液相色谱法/含量测定/溶出度Key words
Valpromide Tablets/high-performance liquid chromatography method/content determination/dissolution rate引用本文复制引用
刘轶,兰文,李晓燕,肖菁,韩曦羽,石笑弋..HPLC法测定丙戊酰胺片的含量及溶出度的研究[J].工业微生物,2025,55(3):19-22,4.基金项目
湖南省科技厅科药联合基金(编号:2022JJ80010). （编号:2022JJ80010）
