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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(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 the determination of maprotiline hydrochloride tablets and dissolution. Methods: Phenomenix C18 column (5μm, 150mm × 4.6mm) was used. The mobile phase was methanol-ammonium sulfate buffer (60:40). The detection wavelength was 230nm and the flow rate was 1mL · min-1. Results: The peaks of maprotiline hydrochloride were symmetrical, the peak purity was 0.9999, the linear range was 0.1000 ~ 1.0000 mg.mL-1 and the average recovery was 99.4%. The linear range of dissolution was 0.0100 ~ 0.1000mg.mL-1, the average recovery. Conclusion: The method is simple and accurate and can be used to determine the content and dissolution of maprotiline hydrochloride tablets.