本文選題：高效液相色譜法 + 富馬酸替諾福韋二吡呋酯��； 參考：《中國藥房》2015年06期

【摘要】：目的:建立測定富馬酸替諾福韋二吡呋酯原料藥和膠囊中有關(guān)物質(zhì)的方法。方法:采用高效液相色譜法。色譜柱為Eclipse XDB-C18,流動相為甲醇-0.05%磷酸溶液(40∶60,V/V)和甲醇(梯度洗脫),檢測波長為260 nm,流速為1.0 ml/min,柱溫為40℃,進(jìn)樣量為20μl。結(jié)果:已知雜質(zhì)替諾福韋單吡呋酯濃度在2.515~20.120μg/ml范圍內(nèi)與峰面積呈良好的線性關(guān)系(r=0.999 9);檢測限為3.75μg/ml,定量限為12.50 ng/ml;精密度、穩(wěn)定性、重復(fù)性試驗(yàn)的RSD分別為0.42%、2.00%、2.67%。按自身對照法測得替諾福韋單吡呋酯含量的結(jié)果偏高。結(jié)論:該方法操作簡便、專屬性強(qiáng)、靈敏度高,可用于富馬酸替諾福韋二吡呋酯原料藥和膠囊中有關(guān)物質(zhì)的測定。
[Abstract]:Objective: to establish a method for the determination of the related substances in tenofovir Fumarate dipyrifuroxime difuroxime and its capsules. Methods: high performance liquid chromatography was used. The chromatographic column was Eclipse XDB-C18. The mobile phase consisted of methanol-0.05% phosphoric acid solution (40: 60 V / V) and methanol (gradient elution). The detection wavelength was 260 nm, the flow rate was 1.0 ml / min, the column temperature was 40 鈩，

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