摘要
目的:建立测定复方芦丁片溶出度的方法。方法:采用HALO5-C18色谱柱(250 mm×4.6 mm,5μm),甲醇-0.4%磷酸溶液(60∶40)(用三乙胺调节pH值至3.0)为流动相;流速1.0ml/min;检测波长254nm。按《中华人民共和国药典》2015年版四部溶出度测定第一法(篮法),采用ERWEKA DT800智能药物溶出仪,通过对溶出介质、转速和取样时间的选择,确定复方芦丁片溶出度测定方法。结果:在本研究建立的色谱条件下,芦丁与维生素C分离度良好。芦丁的线性范围为5.0~40μg/ml(r=0.999 9);维生素C的线性范围为12.5~100μg/ml(r=1.000 0)。样品的溶出度均一性好,以pH 8.0磷酸盐缓冲液作为芦丁溶出介质,0.1mol/L盐酸溶液作为维生素C溶出介质,芦丁取样时间为45min,维生素C取样时间为30min,转速为100r/min。溶出限度均为不低于标示量的80%。结论:本研究建立的方法可用于复方芦丁片溶出度测定,能有效控制药品质量,为提高复方芦丁片质量标准提供依据。
Objective:To develop a method for the determination of the dissolution of compound Rutin tablets.Methods:The chromatographic analysis was carried out on a HALO5-C18column(250mm×4.6mm,5μm)with methanol-0.4% phosphate solution(60∶40)(pH adjusted to 3.0with trimethylamine)as mobile phase.The flow rate was 1.0ml/min and the detection wavelength was 254 nm.According to the first dissolution method(basket method)described in the Pharmacopoeia of the People's Republic of China(2015Edition,Volume 4),the dissolution determination conditions were established using ERWEKA DT800 intelligent drug dissolution instrument,and dissolution medium,rotational speed and sampling time were selected.Results:Rutin and vitamin C could be separated completely under the established chromatographic conditions.The linear ranges of Rutin and vitamin C were 5.0-40μg/ml(r=0.999 9)and 12.5-100μg/ml(r=1.000 0),respectively.The dissolution rates of the samples were consistent.The pH 8.0phosphate buffer solution and 0.1mol/L HCl solution were selected as release media for Rutin and vitamin C,respectively,rotational speed was 100r/min,the sampling time points were 45 and 30min for Rutin and vitamin C,respectively.The dissolution limit was not less than 80% of the labeled amount.Conclusion:This established method could be used for the dissolution determination and the quality control,and provide reference for the improvement of quality standards of compound Rutin tablets.
引文
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