HPLC法测定普瑞巴林胶囊的有关物质  

Determination of the Related Substances of pregabalin Capsules by HPLC

作　　者：陈建征[1] 朱巧[1] 刘秀英[1] 

机构地区：[1]江苏恩华药业股份有限公司,江苏徐州221000

出　　处：《福建分析测试》2016年第3期39-43,共5页Fujian Analysis & Testing

摘　　要：目的:建立HPLC法测定普瑞巴林胶囊的有关物质。方法:采用Shimadzu C18色谱柱(250mm×4.6mm,5μm),以乙腈-0.01mol·L-1磷酸二氢钾溶液(用5mol·L-1氢氧化钾溶液调节p H值至6.5)为流动相进行梯度洗脱;流速为1.0ml·min-1;柱温35℃;检测波长为205nm。结果:各杂质与主峰之间的分离度良好。普瑞巴林、糖基物组分1(Imp1)、糖基物组分2(Imp2)、糖基物组分4和5(Imp3)、糖基物组分7(Imp4)、S-(+)扁桃酸(Imp5)和内酰胺(Imp6)在各浓度区间内峰面积与浓度呈良好的线性关系;Imp1、Imp2、Imp3、Imp4、Imp5和Imp6加样回收率平均值分别为97.74%,96.42%,98.89%,98.28%,99.83%和100.31%;RSD分别为1.52%,1.30%,4.68%,1.44%,1.61%和2.80%。结论:本方法简便、准确可靠,适用于普瑞巴林胶囊中有关物质的控制。Objective： To establish an hplc method for determining the contents of the related substances pregabalin Cap- sules. Methods： The condition of detection were： Shimadzu C18 column （250mm × 4.6mm, 5um） , the gradient mobile phase consisted of acetonitrile and 0.01mol/L potassium dihydrogen phosphate （adjust with 5mol/L potassium hydroxide to pH6.5） with a flow rate of 1.0 mL. min-1, the UV detection wavelength was 205 nm, column temperature was 35℃.Re- suits： The resolution of pregabalin and related substances was good. The calibration curves were linear in the different range for pregabalin, Impl, Imp2, Imp3, Imp4, Imp5 and Imp6, respectively. The average recoveries of pregabalin Impl, Imp2, Imp3, Imp4, Imp5 and Imp6 were 97.74 %, 96.42%, 98.89%, 98.28%, 99.83 % and 100.31% respectively; the RSD were 1.52 %, 1.30%, 4.68%, 1.44%, 1.61% and 2.80% respectively. Conclusion： The method is simple, accurate, reliable and can be used for the quality control of the related substances of pregabalin Capsules.

关 键 词：高效液相色谱法 普瑞巴林胶囊 有关物质 

分 类 号：O657.7[理学—分析化学]