HPLC法测定甲氧氯普胺鼻腔喷雾剂的含量和有关物质  

HPLC determination of metoclopramide and its related substances in metoclopramide nasal spray

作　　者：范先鹏[1,2] 孙建绪[1] 肖军海[1] 汤道权[2] 郑爱萍[1] 

机构地区：[1]军事医学科学院毒物药物研究所,北京100850 [2]徐州医学院药物分析教研室,江苏徐州221004

出　　处：《军事医学》2015年第2期133-135,共3页Military Medical Sciences

基　　金：国家科技重大专项资助项目(2014ZX09J14103-02A)

摘　　要：目的建立测定甲氧氯普胺（MCP）鼻腔喷雾剂含量和有关物质的HPLC检测方法。方法采用Agilent TC-C18柱（250 mm×4.6 mm,5μm）,流动相为乙腈-磷酸盐缓冲液（取0.05 mol/L磷酸二氢钾溶液,加三乙胺5 ml,用磷酸调至p H 4.0）（19∶81）,检测波长为275 nm,柱温30℃,流速为1.0 ml/min。结果与结论在建立的色谱条件下,MCP与有关物质峰基线分离,MCP浓度在10-200μg/ml范围内线性关系良好,r=0.9999,回收率为100.3%-101.6%,RSD为0.68%（n=9）,MCP检出限0.3 ng。该方法准确、可靠,重复性较好,可作为MCP鼻腔喷雾剂的质量控制方法。Objective To establish an HPLC method for the determination of metoclopramide（ MCP） and its related substances in MCP nasal spray. Methods Chromatographic separation was performed on an Agilent TC-C18column（ 250 mm × 4. 6 mm,5 μm） using acetonitrile and phosphate buffer solution（ 0. 05 mol/L potassium dihydrogen phosphate solution,added with 5 ml of triethylamine and adjusted to p H 4. 0 with phosphoric acid）（ 19∶ 81） as the mobile phase at1. 0 ml / min. The detection wavelength was 275 nm and the column temperature was set at 30℃. Results and Conclusion Related substances were completely separated from MCP. For MCP,the linearity of determination was over the range of 10-200 μg / ml and the recovery of the method ranged from 100. 3% to 101. 6%. The relative standard deviation was 0. 68%（ n = 9）. The method is accurate,reliable,repeatable,and could be readily utilized as a quality control method for MSP nasal spray.

关 键 词：甲氧氯普胺鼻腔喷雾剂 高效液相色谱法 有关物质 含量测定 

分 类 号：R927.2[医药卫生—药学] O657.72[理学—分析化学]