HPLC法检测盐酸文拉法辛控释片有关物质含量  

Determination of Related Substances in Venlafaxine Hydrochloride Controlled Release Tablets by HPLC

作　　者：沈丽萍[1,2] 蒋海松[2] 李永吉[3] 

机构地区：[1]黑龙江中医药大学,09级研究生课程班哈尔滨150040 [2]北京科信必成医药科技发展有限公司哈尔滨分公司,哈尔滨150008 [3]黑龙江中医药大学药学院,哈尔滨150040

出　　处：《黑龙江医药》2012年第5期668-671,共3页Heilongjiang Medicine journal

摘　　要：目的:建议以高效液相色谱法检测盐酸文拉法辛控释片中有关物质含量的方法。方法:色谱柱为Ther-moC18,流动相为乙腈-三乙胺缓冲液(取三乙胺10mL,加水稀释至1000mL,用磷酸调节pH至3.0)(20:80),检测波长为225nm,柱温室温,流速为1.0mL/min;以外标法测定定量杂质D、F的含量,以主成分自身对照法计算供试品溶液中其他杂质的含量。结果:该色谱条件下,主成分与有关物质完全分离,各杂质峰分离度良好,最低检测限为0.379ng/mL,杂质D的定量限为44.92ng/mL,杂质F的定量限为116.21ng/mL。结论:该方法专属性强、灵敏度高、重复性好,可用于该制剂中有关物质的检测。Objective:To establish an HPLC method for the determination of related substances in Venlafaxine Hydrochloride Controlled Release Tablets.Methods:The separation was performed on Thermo C18 column with mobile phase consisted of Acetonitrile-triethylamine buffer(take 10mL triethylamine and dilute to 1000 volumes with water,pH = 3.0)(20:80),The detection wavelength was set at 225nm and the column temperature was maintained at room temperature.Flow rate of 1.0 mL·min-1.The content of related substance was calculated by external standard method of quantitative determination of the content of impurity D /F,with principal component itself control method to calculate the product solution other impurity content.Results:the chromatographic conditions,the principal component and related material is completely separated,each impurity peak separation degree good,the minimum detection limit for 0.379 ng/mL,impurity D quantitative limit for 44.92 ng/mL,impurity F quantitative limit for 116.21 ng/mL.Conclusion:this method is a strong specificity high sensitivity and repeatability is good,can be used for the determination of Related Substances in the preparation.

关 键 词：盐酸文拉法辛控释片 有关物质 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]