【摘要】：目的:建立梯度洗脫HPLC法測定阿那曲唑原料藥及片中的有關(guān)物質(zhì)。方法:采用Welch Ultimate C18色譜柱(4.6 mm×250 mm,5μm),流動相A為乙腈-水(40∶60),流動相B為乙腈-水(60∶40),線性梯度洗脫,流速1.0 m L·min-1,柱溫35℃,檢測波長215 nm。結(jié)果:阿那曲唑與6種中間體、副產(chǎn)物完全分離。各雜質(zhì)的線性關(guān)系良好,平均回收率均在97%~113%之內(nèi),重復(fù)性RSD為5.1%,檢測限為0.02~0.04μg·m L-1。有關(guān)物質(zhì)測定結(jié)果:異構(gòu)體為0~0.19%,雜質(zhì)B為0~0.01%,雜質(zhì)C為0~0.04%,雜質(zhì)A為0~0.08%,雜質(zhì)D為0~0.01%,雜質(zhì)E為0~0.04%,其他單個最大雜質(zhì)為0.05%~0.28%,雜質(zhì)總量為0.06%~0.42%。結(jié)論:經(jīng)方法學(xué)驗(yàn)證,本法可用于阿那曲唑及片劑中的雜質(zhì)檢測。
[Abstract]:Objective: To establish a gradient elution HPLC method for the determination of the drug substance and related substances in the drug substance and tablet. Method: Welch Ultimate C18 column (4.6 mm,250 mm,5. mu.m) was used. The mobile phase A was acetonitrile-water (40:60). The mobile phase B was acetonitrile-water (60:40), the linear gradient was eluted, the flow rate was 1.0 m L 路 min-1, the column temperature was 35 鈩，

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