HPLC法测定左旋盐酸去甲苯环壬酯渗透泵片的含量和有关物质

目的建立高效液相色谱（HPLC）法测定左旋盐酸去甲苯环壬酯渗透泵片的含量和有关物质。方法采用C18色谱柱（250 mm×4.6 mm,5μm）,以乙腈-0.05 mol/L醋酸钠缓冲液（85∶15,pH 6.0）为流动相,检测波长为220 nm,流速为1.0 ml/min,柱温为40℃。结果在优化的色谱条件下,左旋盐酸去甲苯环壬酯与有关物质可有效分离,辅料和溶剂不干扰主药测定;主药的线性范围为30.0～200.0μg/ml（r=0.9998）;平均回收率为99.52%,RSD为0.94%（n=9）。结论该方法简便准确,专属性强,可用于测定左旋盐酸去甲苯环壬酯渗透泵片的含量和有关物质。

Determination of the content and related substances of R-(-)-DM-phencynonate hydrochloride osmotic tablets by HPLC

Objective To establish an HPLC method for determination of content and related substances of R-（-）-demethyl（DM）-phencynonate hydrochloride osmotic tablets.Methods The analysis was performed on a C18 column（250 mm×4.6 mm,5μm）,using a mobile phase of acetonitrile-0.05mol/L sodium acetate buffer（85∶15,pH 6.0） at the flow rate of 1.0 ml/min.The detection wavelength was 220 nm.The column temperature was 40℃.Results Under the optimal chromatographic condition,the related substances and R-（-）-DM-phencynonate hydrochloride could be completely separated.A good linear relationship was found between the peak area and the concentration of R-（-）-DM-phencynonate hydrochloride in the range of 30.0-200.0 μg/ml（r=0.9998）.The average recovery was 99.52%（RSD=0.94 %,n=9）.Conclusion The method is simple,accurate and sensitive and applicable for quality control of R-（-）-DM-phencynonate hydrochloride osmotic tablets.