Similarity Evaluation of the Dissolution Curves of Generic and Original Preparation of Losartan Potassium Tablets
10.6039/j.issn.1001-0408.2017.30.33
- VernacularTitle:氯沙坦钾片仿制药与原研药溶出曲线的相似性评价
- Author:
Lichuan SHI
1
;
Xufeng PU
;
Yongxiu YU
;
Chunying LUO
Author Information
1. 成都中医药大学药学院
- Keywords:
Losartan potassium tablet;
Generic preparation;
Original preparation;
Dissolution curve;
UV-visible spectrophotometry;
Similarity factor;
Evaluation
- From:
China Pharmacy
2017;28(30):4298-4301
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To evaluate the dissolution curves similarity of generic and original preparation of Losartan potassium tablets,and to provide reference for improving quality evaluation of the preparation.METHODS:Using hydrochloric acid solution (pH 3.0),phosphate buffer solution(pH 4.5),phosphate buffer solution (pH 6.8) and water as medium,paddle method was adopted for dissolution test with dissolution medium volume of 900 mL and rotation speed of 50 r/min.UV-visible spectrophotometry was adopted to determine accumulative dissolution of generic and original preparation of Losartan potassium tablets with the detection wavelength of 256 um.The similarity of dissolution curves were evaluated by calculating similarity factor(f2).RESULTS:The linear range of losartan potassium was 12.11-35.96 μg/mL (r≥0.999 7).RSDs of precision,stability and reproducibility tests were all lower than 5.0％.The recoveries of 4 dissolution media were 98.66％-100.84％ (RSD=0.77％,n=9),98.91％-100.59％ (RSD=0.49％,n=9),98.33％-101.39％ (RSD=0.85％,n=9),99.46％-101.32％ (RSD=0.55％,n=9).In 4 dissolution media,f2 of the dissolution curves of 3 batches of generic and original preparation of Losartan potassium tablets were all higher than 70.CONCLUSIONS:The dissolution curves of self-made and original preparation of Losartan potassium tablets show good similarity.
