高效液相色谱法测定盐酸美西律片的含量

Content Determination of Mexiletine Hydrochloride Tablets by HPLC

目的:建立HPLC法测定盐酸美西律片的含量。方法:采用AglientXDB-C18(4.6mm×150mm,5μm)色谱柱,流动相为甲醇-水-三乙胺(300∶300∶2)(用冰醋酸调pH至5.5),检测波长261nm。结果:盐酸美西律的线性范围为72.92～255.22mg·mL-1(r=0.9999),回收率为99.3%(n=9),RSD=0.57%。结论:本方法方便、快速、准确,可用于该制剂的质量控制。

Objective： An HPLC method was established for determination of Mexiletine Hydrochloride Tabets. Methods： An Aglient XDB-C18 （4. 6 mm × 150 mm,5 μm） column was used. The mobile was methanol-water-monobasic-triethylamine （300： 300： 2） （adjusted to pH 5.5 with acetic acid ） ,the UV detection wavelength was 261 nm. Results： There was a good linear relationship in the range of 72.92 -255.22 mg · L^-1, r = 0. 999 9 for Mexiletine Hydrochloride. The average recovery was 99. 3% （n = 9） RSD = 0. 57%. Conclusion： This method is simple, sensitive, accurate and can be applied to the quality control of the preparation.