RP-HPLC法测定PAC-1盐酸盐的含量及有关物质  

Determination of procaspase-activating compound one hydrochloride and its related substances by RP-HPLC

作　　者：其其格[1] 陈晓辉[1] 宫平[2] 韩木南[1] 毕开顺[1] 

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016 [2]沈阳药科大学制药工程学院,辽宁沈阳110016

出　　处：《沈阳药科大学学报》2009年第3期210-213,共4页Journal of Shenyang Pharmaceutical University

摘　　要：目的建立RP—HPLC方法测定PAC-1盐酸盐含量并进行有关物质检查。方法采用Kromasil C18色谱柱（150mm×4．6mm，5m），流动相：乙腈-甲醇-磷酸盐缓冲液（30mmol·L-1磷酸二氢钾，体积分数为0．06％的磷酸溶液）（体积比为35：5：60），流速：1．0mL·min-1，UV检测波长：281nm，柱温：35℃。结果PAC—1盐酸盐在2．00～50．10mg·L。内线性关系良好（r=0．9999），平均回收率为100．3％（RSD=0．8％）。PAC-1盐酸盐与其有关物质得到良好分离，检测限为0．2ng。结论本方法可用作PAC-1盐酸盐含量测定和有关物质检查。Objective To establish an HPLC method for determining the content of procaspase-activating compound one （ PAC-1 ） hydrochloride and its related substances. Methods The determination of PAC-1 hydrochloride and the separation of its related substances was performed on a Kromasil C18 column （ 150 mm ×4. 6 mm, 5 μm ）. The mobile phase was acetonitrile-methanol-phosphate buffer solution （30 mmol·L-1 potassium dihydrogen phosphate,0.06% phosphoric acid） （ V： V： V = 35： 5： 60）. The flow rate was 1.0 mL·min-1. Ultraviolet absorption detector was set at 281 nm and column temperature at 35 ℃. Results The linear range of PAC-1 hydrochloride was between 2.00 and 50.10 mg·L-1 （ r =0.999 9）. The average recovery was 100.3% with RSD of 0.8%. The related substances of PAC-1 hydrochloride could be completely separated from PAC-1 hydrochloride. The limit of detection（LOD） was 0.2 ng. Conclusions The method is simple and accurate for quality control of the PAC-1 hydrochloride.

关 键 词：PAC-1盐酸盐 RP—HPLC 有关物质 

分 类 号：R917[医药卫生—药物分析学]