Study on in vitro release consistency between self-prepared Torasemide Sustained-Release Tablet and original preparation
10.7501/j.issn.1674-6376.2017.02.006
- VernacularTitle:自制与原研托拉塞米缓释片体外释放行为的一致性评价
- Author:
Yan HAN
;
Chao MA
;
Dan YANG
;
Ce MENG
;
Xiaowen REN
- Keywords:
Torasemide Sustained-Release Tablet;
dissolution in vitro;
consistency evaluation;
similarity factor
- From:
Drug Evaluation Research
2017;40(2):174-178
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish a method for determining the dissolution oftorasemide sustained-release tablet in vitro and study the methodology of the determination.The consistency of the in vitro release behavior between self-prepared torasemide sustained-release tablet and original preparation were evaluated by constructed method.Methods HPLC method was applied to detect the cumulative release percentage of self-prepared torasemide sustained-release tablet and original preparation in five kinds of release media (water,0.1 mol/L hydrochloric acid solution,pH 4.5 acetate buffer,pH 6.8 phosphate buffer,and 0.1 mol/L hydrochloric acid solution turn to pH 6.8 phosphate buffer).Similarity factor (f2) was used to evaluate the similarity of release curves.Results There was a good linear relationship between the quality concentration of torasemide and peak area in the range of 1.0-12.0 μg/mL (r =0.9995).Results of precision and stability tests were good,and the RSDs for probational liquid were all lower than 2.0％.The average recovery of accuracy test was 100.04％,and RSD was 0.54％ (n =12).The homogeneity of within group of self-prepared preparation met the technical requirement,RSDs of each sampling points in six Dissolution Vessels were lower than 10.0％.The f2 factors of self-prepared torasemide sustained-release tablet and original preparation were 72,60,77,66,and 60 in five kinds of release media.Conclusion The method in the paper is suitable for the release test of torasemide,meanwhile,the self-prepared tablet shows consistent in vitro release behavior with that of the original preparation.
