【摘要】：目的:建立反相高效液相色譜法測(cè)定重組人胰島素中胰島素前體的方法。方法:采用Grace Vydac C18(250mm×4.6mm,5μm)色譜柱為分析柱,以乙腈-0.1%TFA水溶液(20∶80)為流動(dòng)相A,以乙腈-0.1%TFA水溶液(80∶20)為流動(dòng)相B,梯度洗脫,流速為0.8mL·min-1,檢測(cè)波長(zhǎng)為215nm,柱溫為40℃。結(jié)果:胰島素前體在0.76~389.5μg·mL-1范圍內(nèi)峰面積與濃度有良好的線(xiàn)性關(guān)系(r=0.9999),方法平均回收率為103.8%(n=9)。結(jié)論:經(jīng)方法學(xué)驗(yàn)證,本法能準(zhǔn)確測(cè)定重組人胰島素中胰島素前體的含量。
[Abstract]:Objective: to establish a reversed-phase HPLC method for the determination of insulin precursors in recombinant human insulin. Methods: Grace Vydac C18 (250mm 脳 4.6 mm ~ 5 渭 m) column, acetonitrile-0.1 TFA aqueous solution (20:80) as mobile phase, acetonitrile-0.1 TFA aqueous solution (80:20) as mobile phase, gradient elution, flow rate 0.8 mL min-1, detection wavelength 215 nm, column temperature 40 鈩，

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