摘要
目的建立测定甲硝唑芬布芬胶囊中有关物质的HPLC方法。方法采用HPLC法,色谱柱为Agilent SBC_(18)(4.6mm×250mm,5μm),以甲醇-乙腈-水(40∶55∶45)(用磷酸调节pH值至3.0)为流动相A,水为流动相B,进行梯度洗脱,流速:1.0ml·min^(-1),检测波长:300nm,柱温:30℃,进样量:20μl。结果甲硝唑、芬布芬及相关杂质均能较好分离。甲硝唑在0.01~0.2mg·ml^(-1)线性关系良好(r=1.0000),芬布芬在0.01~0.2mg·ml^(-1)线性关系良好(r=0.9996),平均回收率分别为100.71%(RSD为1.16%)和99.17%(RSD为0.69%)。结论本方法灵敏、准确、专属性强,可用于甲硝唑芬布芬胶囊中有关物质的测定。
Objective To establish an HPLC method for determination of related substances of metronidazole and fenbufen capsules.Methods The chromatographic column was Agilent SB-C18 column（4.6 mm×250 mm,5μm）with methanol-acetonitrile-water（40∶55∶45）（adjusted to pH 3.0 with phosphoric acid）as mobile phase A and water as mobile phase B via gradient elution at a flow rate of 1.0 ml·min^-1.The detection wavelength was set at 300 nm,temperature was 30 ℃,and the injection volume was 20μl.Results Metronidazole,fenbufen and their related impurities were completely separated.The linear concentration range of metronidazole was 0.01-0.2 mg·ml^-1 with a correlation coefficient of 1.0000,while that of fenbufen was 0.01-0.2 mg·ml^-1 with a correlation coefficient of 0.9996.The average recovery was 100.71% （RSD=1.16% ）and 99.17% （RSD=0.69% ）respectively.Conclusion This method is sensitive,accurate and specific.It can be used to determine related substances in metronidazole and fenbufen capsules.
出处
《解放军药学学报》
CAS
CSCD
2017年第6期514-516,519,共4页
Pharmaceutical Journal of Chinese People's Liberation Army
