Establishment and verification of dose dumping methodology of Ranolazine Sustained-release Tablets
Objective To establish a measuring method for the dose dumping of Ranolazine Sustained-release Tablets.Methods The dose dumping of Ranolazine Sustained-release Tablets was measured by HPLC.The chromatographic conditions were as follows:the test was carried out on Agilent ZORBAX Extend C18(100 mm×4.6 mm,3.5 μm)The mobile phase was pH 5.0 sodium acetate buffer-Acetonitrile(60∶40,V/V).The detection wavelength was 272 nm and the column temperature was set at 40℃.The dissolution medium involved 900 mL 0.1 mol·L-1 hydrochloric acid solution,0.1 mol·L-1 hydrochloric acid solution containing 5%ethanol(φ),0.1 mol·L-1 hydrochloric acid solution containing 20%ethanol(φ),and 0.1 mol·L-1 hydrochloric acid solution containing 40%ethanol(φ).Dissolution temperature was 37℃±0.5℃.The paddle method was used with the rotational speed of 50 r·min-1,and the dissolution sampling time were 15,30,45,60,75,90,105,120 min.Through the experimental studies of the linearity scope,the solution stability,the precision test,the repeatability,and recovery test,etc,the dose dumping of Ranolazine Sustained-release Tablets was validated.Results The dissolution verification methodology ranolazine had good precision,accuracy,and linearity within the concentration of 0.01-1.10 mg·mL-1 under various medium conditions,and the test solution was stable within 72 h.Conclusion The method can accurately determine the dose dumping of ranolazine Sustained-release Tablets.
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