反相高效液相色谱法测定地拉罗司原料药含量及有关物质
发布时间：2018-09-03 20:11
【摘要】：目的建立地拉罗司原料药含量及有关物质测定的反相高效液相色谱法。方法色谱柱为Phenomenex C_(18)(250mm×4.6mm,5μm),以A[EDTA缓冲液-水-乙腈(100:800:100)]-B[EDTA缓冲液-乙腈(100:900)](100g EDTA,加1000mL水,加磷酸调节pH至2.10±0.10)为流动相进行梯度洗脱,检测波长303nm,流速1.0mL/min,柱温60℃。地拉罗司与相关物质及其降解产物分离度良好。结果地拉罗司在15.00~41.70μg/mL与峰面积呈良好的线性关系(Y=2.8920X+11.939,R~2=0.9995,n=6),回收率在98.5%~100.8%(RSD1.0%,n=3)。结论该方法简便快速、准确灵敏、重复性好,能够用于地拉罗司含量及有关物质测定。
[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 卤0.10) for gradient elution, detection wavelength was 303nm, flow rate was 1.0 mL 路min, column temperature was 60 鈩，
本文编号：2221048
[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 卤0.10) for gradient elution, detection wavelength was 303nm, flow rate was 1.0 mL 路min, column temperature was 60 鈩，
本文编号：2221048
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