盐酸去甲万古霉素纯度控制方法的改进

Improvement of RP-HPLC in the Purity Control of Norvancomycin Hydrochloride

目的 :改进盐酸去甲万古霉素质量控制的方法。方法 :在中国药典与美国药典方法的基础上 ,优化了两种不同的流动相系统 (三乙胺 乙腈 四氢呋喃系统和磷酸氢二铵 甲醇系统 ) ,用梯度洗脱对盐酸去甲万古霉素及其有关物质进行分离。结果 :与中国药典方法相比 ,分离效果显著提高 ,两种方法在 2 .5～ 4 0 μg范围内 ,峰面积与进样量线性关系良好 ,检测限 10ng。结论 :改进后的RP HPLC方法能更加真实的反映去甲万古霉素及其有关物质的含量。

AIM:To improve the method in purity control of norvancomycin hydrochloride. METHOD:On the basis of ChP and USP methods, two different mobile phase systems (triethylamine-acetonitrile-tetrahydrofuran system and phosphate buffer-methanol system)are optimized.Gradient elution is applied in the separation of norvancomycin and its related substances. RESULT:Compared with the current CP method,the separation effect of the optimized methods is remarkably improved. The calibration curves of the two methods are linear between 2.5 μg and 40 μg with a regression coefficient of about 0.9999, and the detection limit is 10 ng. CONCLUSION:The contents of norvancomycin and its related substances can be determinated more accurately by two optimized methods.