HPLC法测定硝酸舍他康唑阴道片的有关物质 点击下载
论文标题: HPLC法测定硝酸舍他康唑阴道片的有关物质
中文摘要: 目的:建立测定硝酸舍他康唑阴道片有关物质的方法。方法:采用高效液相色谱法。色谱柱为Hypersil BDS C18(150 mm×4.6 mm,5 μm),流动相为0.5%醋酸铵溶液-乙腈-甲醇(15 ∶ 42.5 ∶ 42.5,V/V/V),流速为1.0 ml/min,检测波长为220 nm,柱温为25 ℃,进样量为20 μl。结果:硝酸舍他康唑阴道片中有关物质能达到较好的分离;硝酸舍他康唑检测质量浓度线性范围为12.24~28.56 μg/ml(r=0.999 9);精密度、稳定性、重复性试验的RSD<1%;加样回收率为99.38%~99.80%,RSD=0.14%(n=9)。结论:该方法准确、可靠、灵敏度高、专属性强,可用于硝酸舍他康唑阴道片的有关物质测定。
英文摘要: OBJECTIVE: To establish a method for determination of the related substances in Sertaconazole nitrate vaginal tablet. METHODS: HPLC was performed on the column of Hypersil BDS C18(150 mm×4.6 mm, 5 μm) with mobile phase of 0.5% Ammomium acetate solution-acetonitrile-methanol(15 ∶ 42.5 ∶ 42.5,V/V/V) at a flow rate of 1.0 ml/min, detection wavelength was 220 nm, column temperature was 25 ℃, and the injection volume was 20 μl. RESULTS: The related substances in Sertaconazole nitrate vaginal tablet can be well separated; the liner range of sertaconazole nitrate was 12.24-28.56 μg/ml (r=0.999 9); RSDs of precision, stability and reproducibility tests were lower than 1%; recovery was 99.38%-99.80% (RSD=0.14%,n=9). CONCLUSIONS: The method is accurate and reliable with high sensitivity and strong specificity, and can be used for the related substances in Sertaconazole nitrate vaginal tablet.
期刊: 2016年第27卷第15期
作者: 周祥富,王康俊
英文作者: ZHOU Xiangfu,WANG Kangjun
关键字: 硝酸舍他康唑阴道片;有关物质;高效液相色谱法
KEYWORDS: Sertaconazole nitrate vaginal tablet; Related substances; HPLC
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