【摘要】：目的建立地拉羅司原料藥含量及有關(guān)物質(zhì)測定的反相高效液相色譜法。方法色譜柱為Phenomenex C_(18)(250mm×4.6mm,5μm),以A[EDTA緩沖液-水-乙腈(100:800:100)]-B[EDTA緩沖液-乙腈(100:900)](100g EDTA,加1000mL水,加磷酸調(diào)節(jié)pH至2.10±0.10)為流動(dòng)相進(jìn)行梯度洗脫,檢測波長303nm,流速1.0mL/min,柱溫60℃。地拉羅司與相關(guān)物質(zhì)及其降解產(chǎn)物分離度良好。結(jié)果地拉羅司在15.00~41.70μg/mL與峰面積呈良好的線性關(guān)系(Y=2.8920X+11.939,R~2=0.9995,n=6),回收率在98.5%~100.8%(RSD1.0%,n=3)。結(jié)論該方法簡便快速、準(zhǔn)確靈敏、重復(fù)性好,能夠用于地拉羅司含量及有關(guān)物質(zhì)測定。
[Abstract]:Objective to establish a reversed-phase high-performance liquid chromatography (RP-HPLC) for the determination of Dilarosine and its related substances. Methods the chromatographic column was Phenomenex C18 (250mm 脳 4.6mm ~ 5 渭 m),) and A [EDTA buffer -water-acetonitrile (100: 800: 100)] -B [EDTA buffer -acetonitrile (100: 900)] (100g EDTA, + 1000mL water, adjusted pH to 2.10 鹵0.10) for gradient elution, detection wavelength was 303nm, flow rate was 1.0 mL 路min, column temperature was 60 鈩，

本文編號(hào)：2221048