纈沙坦美托拉宗片溶出度檢測(cè)的方法學(xué)研究
發(fā)布時(shí)間：2018-08-22 09:20
【摘要】：目的建立纈沙坦美托拉宗片溶出度測(cè)定方法,并進(jìn)行方法學(xué)驗(yàn)證,為藥品的質(zhì)量控制提供保障。方法采用高效液相色譜法,色譜柱為Agilent SB C18(4.6 mm×250 mm,5μm)色譜柱,流動(dòng)相為乙腈-水(磷酸調(diào)p H值至2.3,比例50∶50),流速1.0 ml/min,檢測(cè)波長(zhǎng)235 nm。結(jié)果纈沙坦在6~120μg/ml濃度范圍內(nèi)線性關(guān)系良好(r=1.0000,n=6),美托拉宗在37.5~750 ng/ml濃度范圍內(nèi)線性關(guān)系良好(r=1.0000,n=6);纈沙坦和美托拉宗的平均回收率分別為99.85%和99.44%,RSD分別為1.05%和1.16%,溶液在24 h內(nèi)穩(wěn)定,濾膜對(duì)兩種藥物均沒(méi)有吸附,兩種藥物的重復(fù)性及中間精密度的相對(duì)標(biāo)準(zhǔn)偏差(RSD)均2%。結(jié)論建立的溶出度檢測(cè)方法操作簡(jiǎn)單,靈敏度及準(zhǔn)確度高,滿足纈沙坦美托拉宗片質(zhì)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.
【作者單位】： 湖北科技學(xué)院藥學(xué)院;軍事醫(yī)學(xué)科學(xué)院毒物藥物研究所;Lipont
【基金】：國(guó)家“重大新藥創(chuàng)制”科技重大專項(xiàng)資助項(xiàng)目(2012ZX09301003-001-009)
【分類號(hào)】：R927.2;O657.72
本文編號(hào)：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.
【作者單位】： 湖北科技學(xué)院藥學(xué)院;軍事醫(yī)學(xué)科學(xué)院毒物藥物研究所;Lipont
【基金】：國(guó)家“重大新藥創(chuàng)制”科技重大專項(xiàng)資助項(xiàng)目(2012ZX09301003-001-009)
【分類號(hào)】：R927.2;O657.72
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