發(fā)布時(shí)間：2018-11-14 15:01

【摘要】：目的:建立加校正因子的主成分自身對(duì)照法測(cè)定瑞格列奈鹽酸二甲雙胍片中瑞格列奈有關(guān)物質(zhì)的含量。方法:采用JK Wp H C18色譜柱(4.6 mm×250 mm,5μm),以30 mmol·L-1磷酸二氫鉀溶液(用磷酸調(diào)節(jié)p H至3.2)-乙腈為流動(dòng)相,梯度洗脫,流速1.5 m L·min-1,檢測(cè)波長(zhǎng)240 nm,柱溫40℃,進(jìn)樣量20μL。測(cè)定瑞格列奈和雜質(zhì)A、B、C的線性方程,以斜率計(jì)算雜質(zhì)相對(duì)于瑞格列奈的校正因子,用相對(duì)保留時(shí)間確定各雜質(zhì)位置。并進(jìn)行了方法學(xué)驗(yàn)證。用相對(duì)校正因子計(jì)算復(fù)方片劑中瑞格列奈雜質(zhì)A、B、C的含量,并與雜質(zhì)對(duì)照品法測(cè)得的結(jié)果進(jìn)行比較。結(jié)果:瑞格列奈雜質(zhì)A、B、C的相對(duì)保留時(shí)間分別為0.10、0.35、0.48,校正因子分別為0.65、0.76、3.06。檢出限分別為0.27、0.12、4.21 ng,定量限分別為0.8、0.4、12.2 ng。采用校正因子的主成分自身對(duì)照法和外標(biāo)法測(cè)得的結(jié)果無(wú)顯著性差異。結(jié)論:本方法經(jīng)方法驗(yàn)證,可準(zhǔn)確測(cè)定復(fù)方片劑中瑞格列奈3種雜質(zhì)的含量。
[Abstract]:Objective: to establish a principal component self-control method for the determination of related substances in reaglinide hydrochloride metformin hydrochloride tablets. Methods: JK Wp H C18 column (4.6 mm 脳 250 mm,5 渭 m),) was used with 30 mmol L-1 potassium dihydrogen phosphate solution (adjusted with phosphoric acid to adjust pH to 3.2) -acetonitrile as mobile phase, gradient elution, flow rate 1.5 mL min-1,. The detection wavelength is 240 nm, the column temperature is 40 鈩，

本文編號(hào)：2331506