HPLC法测定盐酸马普替林片的含量及溶出度  

HPLC determination of maprotiline hydrochloride tablets and its dissolution

作　　者：夏瑞[1] 车宝泉[1] 田洁[1] 董素英[1] 

机构地区：[1]北京市药品检验所,北京100035

出　　处：《药物分析杂志》2009年第10期1729-1733,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的：建立HPLC法测定盐酸马普替林片含量及溶出度。方法：采用PhenomenixC18柱（5μm，150mm×4．6mm），流动相为甲醇-硫酸铵缓冲液（60：40）；检测波长为230nm，流速为1mL·min^-1。结果：盐酸马普替林色谱峰峰形对称，峰纯度检查为0．9999，含量测定方法的线性范围在0．1000～1．0000mg·mL^-1，平均回收率为99．4％；溶出度测定的线性范围为0．0100～0．1000mg·mL^-1，平均回收率。结论：本测定方法简便、准确，可用于盐酸马普替林片的含量及溶出度的测定。Objective：To establish an HPLC method for determination of content and dissolution of maprotiline hydrochloride tablets. Method：A Phenomenix C18 column （5 μm,150mm×4.6mm ） was adopted with mobile phase consisted of ammonium sulfate buffer solution - methanol （40： 60） at the flow rate of 1 mL · min^-1. The de- tection wavelength was 230 nm. Result： Maprotiline hydroehloride peak was symmetrical in the chromatograph, the peak purity index is 0. 9999. The linear range was 0. 1000 - 1. 0000 mg · mL^-1 for assay, the average recovery was 99.4%, and for dissolution the linear range was 0. 0100 -0. 1000 mg ·mL^-1, the average recovery was 99.6%. Conclusion：This method is simple, specific and can be use for the determination of maprotiline hydrochloride tablets and its dissolution.

关 键 词：盐酸马普替林片 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]