【摘要】：目的建立HPLC法測定利伐沙班原料藥的有關(guān)物質(zhì)。方法采用Purospher Star RP-18endcapped(55mm×4.0mm,3μm)色譜柱;10mmol·L-1磷酸為流動相A,乙腈為流動相B,梯度洗脫;進(jìn)樣量為5μL;檢測波長為250nm;流速為1.0mL·min-1;柱溫為45℃。結(jié)果利伐沙班及各雜質(zhì)能得到良好的分離,3批樣品中單一雜質(zhì)的含量質(zhì)量分?jǐn)?shù)均小于0.1%。結(jié)論該方法可用于利伐沙班原料藥中有關(guān)物質(zhì)的檢測。
[Abstract]:Objective to establish a HPLC method for the determination of related substances in rivastaban. Methods Purospher Star RP-18endcapped column (55mm 脳 4.0 mm ~ (3 渭 m) was used as mobile phase A, acetonitrile as mobile phase B, injection volume 5 渭 L, detection wavelength 250 nm, flow rate 1.0mL min-1; column temperature 45 鈩，

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