HPLC法测定恩格列净有关物质的方法学验证

发布时间：2018-06-18 16:25

  本文选题：恩格列净 + 有关物质　； 参考：《南京医科大学学报(自然科学版)》2017年01期

【摘要】：目的:建立恩格列净原料药纯度及所含杂质的测定方法。方法:采用高效液相色谱(HPLC)法,用Waters symmetry C18色谱柱(250 mm×4.6 mm,5μm),以0.01%(V/V)三氟乙酸溶液为流动相A,乙腈为流动相B,线性梯度洗脱:0~10 min,流动相B 32%;10~50 min,流动相B 32%~95%;检测波长225 nm,流速1.0 m L/min,柱温45℃。结果:恩格列净与各杂质的分离度均1.5,检出限均9 ng/m L,线性范围满足定量分析要求;重复性试验相对标准差(RSD)均5%;供试品溶液和对照溶液在8 h内稳定性良好;各杂质的回收率为88.6%~106.1%,RSD均10%。结论:本研究建立的方法检测灵敏度高,精密度好,可作为恩格列净原料药有关物质的控制方法。
[Abstract]:Objective: to establish a method for the determination of purity and impurity in Englicine raw material. Methods: high performance liquid chromatography (HPLC) was used. Waters symmetry C18 column was used as the mobile phase A, acetonitrile as the mobile phase, the mobile phase as a mobile phase, acetonitrile as the mobile phase, the mobile phase as a gradient elution for 10 minutes, the mobile phase as the mobile phase for 10 ~ 1050 minutes, the mobile phase as the mobile phase, the detection wavelength was 225 nm, the flow rate was 1.0 mL / min, and the column temperature was 45 鈩，

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