Similarity Evaluation of Dissolution Profiles of Self-development and Original Preparation of Solifenacin Suc-cinate Tablet
10.6039/j.issn.1001-0408.2016.30.44
- VernacularTitle:琥珀酸索利那新片自研制剂与原研制剂溶出曲线的相似性评价
- Author:
Junqiang GONG
;
Xian CHEN
;
Caihong XU
;
Xia ZHANG
;
Chunmei WU
;
Ping WANG
;
Xuchun FU
- Publication Type:Journal Article
- Keywords:
Solifenacin succinate tablet;
Self-development;
Original preparation;
HPLC;
Dissolution profiles;
f2 similarity fac-tor;
Evaluation
- From:
China Pharmacy
2016;27(30):4311-4314
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To explore the similarity of dissolution profiles of self-development and original preparation of Solife-nacin succinate tablet,and provide reference for the prescription and process screening of the former one and the quality similarity evaluation of the latter one. METHODS:The paddle method was adopted with rotational speed of 50 r/min,using water,pH1.2 hy-drochloric acid solution,pH4.0 acetate buffer solution and pH6.8 phosphate buffer solution as dissolution media,HPLC was used to determine the cumulative dissolution of main components of self-development and original preparation of Solifenacin succinate tablet at different time points,dissolution profile was drew,then f2 was used to evaluate its similarity. RESULTS:In the 4 dissolu-tion media,the f2 of both self-development and original preparation of Solifenacin succinate tablet was higher than 50,which indi-cated that the dissolution profiles showed similarity. CONCLUSIONS:The established HPLC is suitable for the dissolution determi-nation of Solifenacin succinate tablet;the dissolution profiles of the self-development and original preparations are basically simi-lar,which indicates the prescription and technology of self-development preparation are feasible.
