反相高效液相色谱法测定盐酸美西律片的含量

Determination of Mexiletine Hydrochloride Tablets by HPLC

目的建立测定盐酸美西律片含量的反相高效液相色谱法。方法采用Agela Venusil XBP-C18色谱柱(250 mm×4.6 mm,5μm),以甲醇-冰醋酸调pH至(5.8±0.1)的0.1 mol/L的醋酸钠(50∶50)为流动相,柱温为室温,流速1.0 mL/min,检测波长216 nm,进样量为20μL。结果盐酸美西律质量浓度在6.25～75μg/mL范围内与峰面积呈良好的线性关系,r=0.999 9(n=7);高、中、低3种质量浓度的平均回收率为99.68%,RSD=0.90%(n=9)。结论该方法快速、准确、专属性强。

Objective A method for the determination of Mexiletine Hydrochloride Tablets by HPLC was establish. Methods The de- termination was performed on a Agela Venusil XBP-C18（250 mm×4.6 mm,5 μm） column with the mobile phase consisting of methanol-0. 1 mol/L sodium acetate solution（50 ： 50,pH was adjusted to 5.8 ±0. 1 with acetic）at ambient temperature. The flow rate was 1.0 mL/min. The detection wavelength was 216 nm. The injection volume was 20μL. Results The method showed a good linear relationship within the range of 6.25-75 μg/mL, r=0.999 9（n=7）. The average recovery was 99.68% for the three different levels of the added amount of mexiletine hydrochloride with RSD = 0. 90% （n = 9）. Conclusion This method is rapid,specific and accurate.