Evaluation of dissolution consistency of Iloperidone Tablets
10.7501/j.issn.1674-6376.2017.02.004
- VernacularTitle:伊潘立酮片溶出度一致性评价研究
- Author:
Nan MI
;
Chao MA
;
Simeng FANG
;
Kexin ZANG
;
Mujun SU
- Keywords:
Iloperidone Tablets;
dissolution;
consistency evaluation;
f2 factor
- From:
Drug Evaluation Research
2017;40(2):164-168
- CountryChina
- Language:Chinese
-
Abstract:
Objective To compare the dissolution curves of reference preparation and self-prepared Iloperidone Tablets in four different pH dissolution media (0.1 mol/L HC1 solution,pH 4.5 acetate buffer solution,pH 6.8 phosphate buffer solution,and water).Methods The solubility of Iloperidone in different pH solutions was measured,the dissolution curves of two preparations in four different pH dissolution media were determined by HPLC,and the similarity was investigated according to the f2 factor method.Results The f2 factors between reference preparation and self-prepared Iloperidone Tablets in four different media were more than 50.Conclusion The two preparations are equivalent in four different pH dissolution media in vitro.