Dissolution Determination of Tamibarotene Tablet by HPLC

VernacularTitle:HPLC法测定他米巴罗汀片的溶出度
Author: Lijiao CHEN ; Dongxia YANG ; Yanxia ZHAO
Publication Type:Journal Article
Keywords: HPLC; Tamibarotene tablet; Dissolution
From: China Pharmacy 2016;27(30):4304-4306
CountryChina
Language:Chinese
Abstract: OBJECTIVE:To establish a method for the dissolution determination of Tamibarotene tablet. METHODS:HPLC was performed on the column of Diamonsil C18 with mobile phase of methanol-water-acetic acid(85∶15∶1,V/V/V)at a flow rate of 1.0 ml/min,detection wavelength was 235 nm,column temperature was 25 ℃,and injection volume was 20 μl. The paddle method was used to determine the dissolution,using pH6.8 phosphate buffer dissolution as medium,medium volume was 900 ml,the rotat-ing speed was 50 r/min,taking samples after 60 min. RESULTS:The linear range of tamibarotene was 0.801-2.804 μg/ml (r=0.999 6);RSDs of precision,stability and reproducibility tests were lower than 3%;recovery was 99.58%-100.90%(RSD=0.25%,n=9);the accumulative dissolution rate of 3 batches of samples was 98.25%,96.54%,92.38%(n=6). CONCLUSIONS:The method simple,accurate with high sensitivity and specificity,and suitable for the dissolution determination of Tamibarotene tablet.