Determination of content of rosiglitazone hydrochloride tablets and related substance by HPLC

Objective To establish a HPLC method to determine the content and related substance of rosiglitazone hydrochloride tablets.Methods The analysis was achieved on a Diamonsil C18 column(250 mm×4.6 mm,5 μm) using a mobile phase of 0.025 mol/L ammonium acetate-acetonitrile(50∶50).The detection wavelength was at 245 nm.Results There was good resolution among the peak of rosiglitazone,the main related substances and the degradable impurities after being destroyed.There was a good linear relationship between the peak area and the concentration of rosiglitazone in the range of 19.57～195.70 μg/ml(r=1.000 0,n=6).Regression equation could be expressed by A=68 525C+31 152,r=1.000 0(n=6).The precision in a day(RSD﹤0.5%) and during the days(RSD﹤1.0%) were good.The average recovery was 99.8%(RSD=0.3%,n=9) and the limit of detection was 0.29 ng.The solution was stable for 10 hours.Conclusion The method was specific,accurate,sensitive and could be used to determine rosiglitazone.