摘要
目的 建立科学合理的HPLC法测定马来酸曲美布汀片的有关物质及含量.方法 用三个标准测定样品,综合考虑分离效果、含量测定结果、有关物质测定结果等几方面,选择标准Ⅰ为转正标准的HPLC条件,色谱条件为 C18色谱柱,流动相为0.01 mol·L^-1高氯酸溶液（0.1%醋酸铵溶液调节pH为3.75±0.05,加入1.54 g·L^-1的戊烷磺酸钠）-乙腈（65∶35）,流速为1.0 ml·min-1,检测波长为268 nm,进样量为20 μl.结果 用三个标准测定样品的有关物质,最大杂质均未过0.5%,总杂质均未过1.0%;在0.2～400 mg·L^-1浓度范围内呈良好线性关系;含量测定的平均回收率为99.8%,RSD为0.6%.结论 标准Ⅰ灵敏度高,线性范围宽,回收率高,可作为转正标准的HPLC方法.
Aim To establish a method of HPLC for determining the related substance and content of trimebutine maleate tablets.Methods Samples were determined by three standards.The results of resolution,content and related substance were analyzed and standard Ⅰ was chosen as HPLC method of formal standard.Chromatographic condition is C18 column and mobile phase is 0.01 mol·L^-1 Perchloric Acid（adjusted to pH3.75 with 0.1% ammonium acetate added with to 1.54 g·L^-1 sodium 1-pentanesulfonate）-acetonitrile（65∶35）.The flow rate was 1.0 ml·min^-1.UV detector wavelength was 268 nm. Injection volume is 20 μl.Results Impurities of samples were determined with three standards.The highest impurity was not more than 0.5% and the total impurities was not more than 1.0%.A good linear was within the range of 0.2～400 mg·L^-1.The average recovery was 99.8%,and RSD were 0.6%.Conclusion Standard Ⅰ shows high sensitivity,wide linearity range,good recovery and could be used as HPLC method of formal standard.
出处
《安徽医药》
CAS
2007年第8期701-703,共3页
Anhui Medical and Pharmaceutical Journal
