高效液相色譜法測(cè)定丁酸氯維地平脂肪乳注射液的有關(guān)物質(zhì)
發(fā)布時(shí)間:2018-04-30 08:46
本文選題:丁酸氯維地平 + 脂肪乳 ; 參考:《中國(guó)新藥雜志》2015年16期
【摘要】:目的:建立高效液相色譜法測(cè)定丁酸氯維地平脂肪乳注射液有關(guān)物質(zhì)的方法。方法:采用Symmetry shield RP18色譜柱(150 mm×4.6 mm,3.5μm),流動(dòng)相為50 mmol·L-1磷酸二氫鈉溶液(稀磷酸調(diào)節(jié)p H值至4.0)-乙腈-甲醇(40∶25∶35),流速為1.0 m L·min-1,檢測(cè)波長(zhǎng)為220 nm,柱溫為30℃。結(jié)果:丁酸氯維地平與各相關(guān)雜質(zhì)分離良好,輔料不干擾測(cè)定,在0.40~2.49μg·m L-1范圍內(nèi),丁酸氯維地平濃度與峰面積呈良好的線性關(guān)系,線性關(guān)系曲線為A=53 239C-92.246(r=0.999 8,n=6),氯維地平的定量限為100 ng·m L-1(相對(duì)濃度0.04%)。結(jié)論:本方法操作簡(jiǎn)便準(zhǔn)確,靈敏度高,適用于丁酸氯維地平脂肪乳注射液有關(guān)物質(zhì)檢查。
[Abstract]:Objective: to establish a HPLC method for the determination of related substances in clovedipine butyrate fat emulsion injection. Methods: a Symmetry shield RP18 column of 150mm 脳 4.6mm ~ 3.5 渭 m ~ (-1) was used. The mobile phase was 50 mmol L ~ (-1) sodium dihydrogen phosphate solution (adjusted by dilute phosphoric acid to 4.0: 25: 25: 35), the flow rate was 1.0 mL 路min ~ (-1), the detection wavelength was 220nm and the column temperature was 30 鈩,
本文編號(hào):1823881
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