RP-HPLC-UV法测定盐酸雷诺嗪原料药及有关物质的含量

Detection of the contect of ranolzaine hydrochloride and related compounds by RP-HPLC-UV

目的建立RP—HPLC—uV法用于盐酸雷诺嗪的含量和有关物质测定。方法采用WatersXBRIDGEC。8色谱柱（250mm×4．6mm，5μm），流动相为乙腈一20mmol·L^-1磷酸二氢钾溶液（用三乙胺调节pH值至7．0）（体积比40：60），流速为1．0mL·min^-1，检测波长为215nm，进样量为10μL。结果盐酸雷诺嗪质量浓度在9．068—226．7mg·L^-1内线性关系良好（r=0．9996），重复性试验RSD为0．96％，主峰与各杂质均具有较好的分离度。结论该方法快速、准确、专属性强，适用于盐酸雷诺嗪及其制剂的质量控制。

Objective To establish an HPLC-UV method for the detection of ranolzaine hydrochloride and re- lated compounds. Methods A Waters XBRIDGE C18 column （250 mm ×4.6mm,5μm） was used;the mo- bile phase consisted of acetonitrile-KH2PO4 solution （20 mmol. L ^-1 , adjusted to pH 7.0 with triethylamine） （ V： V=40：60） ;the flow rate was set at 1.0 mL.min^-1 and the detector was set at 215 nm with an injection volume of 10 μL. Results The linear range was 9. 068-226. 7 mg.L^-1 （r =0. 999 6）. The relative standard deviation for precision was 0. 2%. The resolution between ranolazine and corresponding related substances was good. Conclusions The present method is rapid, accurate, sensitive, and suitable for the quality control of ranolazine hydrochloride and its formulations.