RP-HPLC测定雷诺嗪含量及有关物质

Quantification of ranolzaine and its relevant substances by RP-HPLC

目的:建立测定雷诺嗪(ranolazine)含量及有关物质的反相高效液相色谱法。方法:依利特Hypersil BDS C_(18)硅烷键合硅胶柱(250mm×4．6mm,5μm),流动相:甲醇-7mmol·L^(-1)醋酸铵与3．5mmol·L^(-1)醋酸的缓冲液(65:35),流速:1．0mL·min^(-1),柱温:30℃,检测波长:272nm。结果:雷诺嗪在0．102～2．034mg·mL^(-1)的范围内,浓度和峰面积线性良好,r=0．9999。重复性试验的RSD为0．92%。结论:测定方法简便快速、重现性好、准确度高,可适用于雷诺嗪的含量测定及其有关物质检查。

Objective：To establish a RP-HPLC method for the quantification of ranolazine and its relevant substances. Methods; The RP-HPLC conditions was as followed： a Hypersil BDS C18 column （250 mm×4.6 mm,5μm） with a column temperature at 30℃ a mobile phase consisted of methanol-7mmol·L^-1 ammonium acetate ： 3.5mmol·L^-1 acetic acid （65 ： 35 ） with a flow rate of 1.0 mL·min^-1 and a detection wavelength at 272.nm. Results：The linearity of ranolazine concentration was within 0. 102 ～ 2. 034mg·mL^-1 （ r = 0. 999 9） with RSD of 0.92%. Conclusion ： The reliable and rapid RP-HPLC method to quantify ranolazine and its relevant is achievable.