摘要
目的 建立雷诺嗪缓释片剂量倾泻的测定方法.方法 采用高效液相色谱法,色谱条件:以Agilent ZORBAX Extend C18(100 mm×4.6 mm,3.5 μm)为色谱柱,以pH 5.0 的乙酸钠缓冲液-乙腈(体积比60∶40)为流动相,流速为1.0 mL·min-1,检测波长为272 nm,柱温为40℃,进样量为5 μL.溶出条件:以900 mL 浓度为0.1 mol·L-1盐酸溶液、含体积分数为5%乙醇的0.1 mol·L-1盐酸溶液、含体积分数20%乙醇的0.1 mol·L-1盐酸溶液、含体积分数40%乙醇的0.1 mol·L-1 盐酸溶液为溶出介质,溶出温度为(37±0.5)℃,转速为 50 r·min-1,桨法,分别经 15、30、45、60、75、90、105、120 min,取续滤液进行考察.通过系统适用性、专属性、精密度、线性和范围、滤膜吸附、准确度、溶液稳定性等试验研究,对雷诺嗪缓释片的剂量倾泻方法进行验证.结果 该方法学验证结果良好,各介质条件下,雷诺嗪在质量浓度为 0.01～1.10 mg·mL-1 浓度范围内精密度、准确度、线性良好,供试品溶液在72h内稳定.结论 本方法能准确测定雷诺嗪缓释片的剂量倾泻.
Abstract
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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