HPLC法测定盐酸马普替林片的含量及溶出度___

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Phenomenix C18柱（5 μm,150 mm×4.6 mm ），流动相为甲醇-硫酸铵缓冲液（60∶40） 检测波长为230 nm，流速为1 mL•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0.1000～1.0000 mg•mL-1，平均回收率为99.4% 溶出度测定的线性范围为0.0100～0.1000 mg•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 C18column（5 μm,150 mm×4.6 mm ）was adopted with mobile phase consisted of ammonium sulfate buffer solution-methanol (40∶60) at the flow rate of 1 mL•min-1.The detection wavelength was 230 nm.Result:Maprotiline hydrochloride 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.