高效液相色谱法测定瑞替加滨及其有关物质.docx

高效液相色谱法测定瑞替加滨及其有关物质 1. Introduction retiga鄙视（国际未指定名称）/ezoga鄙视（扩展名）ian-4-（4-fan-phenyl）chelbackandc。 In this paper, we described the determination of Retigabine and its related substances in drug substances using an HPLC method without ion-pair reagent as the mobile phase. To our knowledge, no such HPLC method that can carry on an accurate and quantitative analysis of degraded products and related substances of Retigabine has been reported in the literature. This method was successfully validated in terms of specificity,limit of detection (LOD), limit of quantification (LOQ),linearity, precision, accuracy and robustness. Forced degradation studies were performed on the drug substances to show the stability-indicating nature of this method. 2. 母乳喂养 2.1. 非参数检索repond Retigabine was purchased from Toronto Research Chemicals Inc (Toronto, Canada). Six impurities (imp-1,imp-2, imp-3, imp-4, imp-5 and imp-6) were produced by our own laboratory and determined by infrared spectroscopy (IR), liquid chromatography-tandem mass spectrometry (LC-MS/MS), and nuclear magnetic resonance (NMR). Triethylamine was obtained from Tianjin Guangfu Fine Chemical Research Institute (Tianjin,China). Acetonitrile was supplied by Anhui Fulltime Specialized Solvents Reagents CO., LTD (Anhui,China). All the other reagents were of analytical grade. 2.2. perf添加 Chromatographic separations were performed on Agilent Eclipse Plus C 2.3. ucdalc-10atvplus和scl-10amplus Chromatographic analysis was performed on LC10AVP system obtained from Shimadzu Corp. (Kyoto,Japan), which included a LC-10ATVP Plus, SCL-10AVP Plus, a CTO-10ASVP Plus, and a SPD-M10AVP Plus.Chromatographic data were processed using the LC solution Lite. Other apparatus included a DL-60D ultrasonic device (Shanghai, China), a PHS-3CW digital p H meter (Shanghai LIDA Instrument Factory, Shanghai,China) and an AB-135S balance (METTLER TOLEDO). 2.4. 内皮拉斯类型 2.4.1. tiathy-la工作repole The diluent solution was prepared by mixing the triethylamine