Dissolution determination of new Dihydroartemisinin Tablets.
10.19540/j.cnki.cjcmm.20181221.003
- Author:
Dong ZHANG
1
;
Yan TONG
1
;
Tao YUAN
2
;
Jin-Yu WANG
1
;
Lan YANG
1
Author Information
1. Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences Beijing 100700,China.
2. Xinjiang Technical Institute of Physics and Chemistry,Chinese Academy of Sciences Urumqi 830011,China.
- Publication Type:Journal Article
- Keywords:
Dihydroartemisinin Tablets;
HPLC;
dihydroartemisinin;
dissolution determination
- MeSH:
Artemisinins;
chemistry;
Chromatography, High Pressure Liquid;
Solubility;
Tablets
- From:
China Journal of Chinese Materia Medica
2019;44(6):1273-1277
- CountryChina
- Language:Chinese
-
Abstract:
New Dihydroartemisinin Tablets were prepared,and a new dissolution determination method for the tablets was established,which provides reference for revising the quality standard.The dissolution experiment adopted the paddle method with 0.1 mol·L~(-1)hydrochloric acid solution 250 m L as the solvent,the rotating speed of 100 r·min~(-1)and the sampling time of 30 min.HPLC was adopted to determine the dissolution of dihydroartemisinin.The determination was performed on Agilent Eclipse XDB-C_(18)column with the mobile phase of acetonitrile-water(40∶60)at the flow rate of 1.0 m L·min~(-1).The detection wavelength was set at 216 nm,and the column temperature was 30℃.The sample size was 100μL.The linear range of dihydroartemisinin were 1.234 5-79.003 ng(r=1.000 0).The limit of quantitation was 0.308 6 ng,and the limit of detection was 0.154 3 ng.RSDs of precision tests were all lower than 1.0%.The recoveries were 98.09%-102.6%(RSD 1.8%,n=9).The average dissolutions of dihydroartemisinin in 3 batches of samples were 93.81%,92.61%,92.37%,respectively.The determination method is highly reproducible,accurate and reliable,and can objectively reflect the dissolution of Dihydroartemisinin Tablets,and provide a basis for revising the dissolution test of the current quality standard.Based on the dissolution rate,new tablets are superior to original tablets.
