缬沙坦美托拉宗片溶出度检测的方法学研究
发布时间：2018-08-22 09:20
【摘要】：目的建立缬沙坦美托拉宗片溶出度测定方法,并进行方法学验证,为药品的质量控制提供保障。方法采用高效液相色谱法,色谱柱为Agilent SB C18(4.6 mm×250 mm,5μm)色谱柱,流动相为乙腈-水(磷酸调p H值至2.3,比例50∶50),流速1.0 ml/min,检测波长235 nm。结果缬沙坦在6~120μg/ml浓度范围内线性关系良好(r=1.0000,n=6),美托拉宗在37.5~750 ng/ml浓度范围内线性关系良好(r=1.0000,n=6);缬沙坦和美托拉宗的平均回收率分别为99.85%和99.44%,RSD分别为1.05%和1.16%,溶液在24 h内稳定,滤膜对两种药物均没有吸附,两种药物的重复性及中间精密度的相对标准偏差(RSD)均2%。结论建立的溶出度检测方法操作简单,灵敏度及准确度高,满足缬沙坦美托拉宗片质量控制的要求。
[Abstract]:Objective to establish a method for the determination of dissolution of valsartan Metorazone tablets and to provide guarantee for drug quality control. Methods High performance liquid chromatography was used. The column was Agilent SB C18 (4.6 mm 脳 250 mm). The mobile phase consisted of acetonitrile-water (phosphoric acid adjusted pH to 2.3, the ratio was 50:50), the flow rate was 1.0 ml / min, and the detection wavelength was 235 nm. Results there was a good linear relationship between valsartan and metozon in the concentration range of 6 ~ 120 渭 g/ml (r = 1.00) and that of metoprozon in the range of 37.5 ~ 750 ng/ml (r = 1.00), the average recoveries of valsartan and metoprozon were 99.85% and 99.44%, respectively, and were 1.16% and 1.16%, respectively, and the solution was stable within 24 h, and the relative standard of valsartan and metoprozon were 1.05% and 1.16, respectively, and the average recoveries of valsartan and metoprozon were 1.05% and 1.16, respectively. The two drugs were not adsorbed by the filter membrane, and the reproducibility of the two drugs and the relative standard deviation (RSD) of the intermediate precision were all 2. Conclusion the established dissolution assay is simple, sensitive and accurate, and can meet the requirements of quality control of valsartan Metorazone tablets.
【作者单位】： 湖北科技学院药学院;军事医学科学院毒物药物研究所;Lipont
【基金】：国家“重大新药创制”科技重大专项资助项目(2012ZX09301003-001-009)
【分类号】：R927.2;O657.72
本文编号：2196669
[Abstract]:Objective to establish a method for the determination of dissolution of valsartan Metorazone tablets and to provide guarantee for drug quality control. Methods High performance liquid chromatography was used. The column was Agilent SB C18 (4.6 mm 脳 250 mm). The mobile phase consisted of acetonitrile-water (phosphoric acid adjusted pH to 2.3, the ratio was 50:50), the flow rate was 1.0 ml / min, and the detection wavelength was 235 nm. Results there was a good linear relationship between valsartan and metozon in the concentration range of 6 ~ 120 渭 g/ml (r = 1.00) and that of metoprozon in the range of 37.5 ~ 750 ng/ml (r = 1.00), the average recoveries of valsartan and metoprozon were 99.85% and 99.44%, respectively, and were 1.16% and 1.16%, respectively, and the solution was stable within 24 h, and the relative standard of valsartan and metoprozon were 1.05% and 1.16, respectively, and the average recoveries of valsartan and metoprozon were 1.05% and 1.16, respectively. The two drugs were not adsorbed by the filter membrane, and the reproducibility of the two drugs and the relative standard deviation (RSD) of the intermediate precision were all 2. Conclusion the established dissolution assay is simple, sensitive and accurate, and can meet the requirements of quality control of valsartan Metorazone tablets.
【作者单位】： 湖北科技学院药学院;军事医学科学院毒物药物研究所;Lipont
【基金】：国家“重大新药创制”科技重大专项资助项目(2012ZX09301003-001-009)
【分类号】：R927.2;O657.72
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