HPLC法测定盐酸倍他司汀口服液中的有关物质

发布时间：2018-11-19 15:38

【摘要】：目的建立反相HPLC法测定盐酸倍他司汀口服液中有关物质含量。方法采用Diamonsil C18色谱柱(150 mm×4.6 mm,5μm),流动相:p H 4.7的醋酸铵缓冲溶液(650 m L,约含2.88 g十二烷基硫酸钠)-乙腈(体积比为65∶35),流速:1.0 m L·min-1,进样量:20μL,检测波长:261 nm,柱温:40℃。结果在该色谱条件下,3批样品中各杂质质量分数分别为,杂质A(×10-2):6.385%、6.247%、6.164%;杂质B(×10-2):4.901%、4.916%、4.741%;杂质C未检测到;其他单个最大杂质(×10-2):6.329%、5.892%、5.306%;总杂质(×10-1):2.209%、2.119%、2.022%。结论该方法可用于盐酸倍他司汀口服液中有关物质的检查。
[Abstract]:Objective to establish a reversed-phase HPLC method for the determination of related substances in betastine hydrochloride oral liquid. Methods the Diamonsil C18 column (150 mm 脳 4.6 mm,5 渭 m), mobile phase,: p H 4.7) was used as an ammonium acetate buffer solution (650ml, containing about 2.88g sodium dodecyl sulfate) -acetonitrile (65:35 by volume). Flow rate: 1.0 mL min-1, injection: 20 渭 L, detection wavelength: 261 nm, column temperature: 40 鈩，

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