HPLC法测定注射用泮托拉唑钠中的有关物质

发布时间：2019-02-15 17:54

【摘要】：目的:建立测定注射用泮托拉唑钠中有关物质的方法。方法:采用高效液相色谱法。色谱柱为Kromasil Hypersil ODS,流动相为0.01 mol/L磷酸氢二钾溶液(调节pH为7.0)-乙腈(梯度洗脱),流速为1.0 mL/min,检测波长为290 nm,柱温为40℃,进样量为20μL。结果:杂质A、B、C+E、D检测质量浓度线性范围分别为0.416 8~1.042 0μg/mL(r=0.999 8)、0.195 0~0.487 5μg/mL(r=0.999 9)、0.389 0~0.972 5μg/mL(r=0.999 8)、0.198 6~0.496 5μg/mL(r=0.999 8);定量限分别为0.834、0.780、1.556、0.794ng/mL,检测限分别为0.417、0.390、0.778、0.397 ng/mL;精密度试验的RSD1.0%,重复性试验中总杂质峰面积的RSD1.0%;回收率分别为98.81%~102.49%(RSD=1.18%,n=9)、95.31%~98.44%(RSD=0.91%,n=9)、96.88%~98.44%(RSD=0.52%,n=9)、97.87%~101.28%(RSD=1.05%,n=9)。结论:该方法简便、准确,可用于注射用泮托拉唑钠中有关物质的测定。
[Abstract]:Objective: to establish a method for the determination of related substances in pam Tora sodium for injection. Methods: high performance liquid chromatography was used. The chromatographic column consisted of Kromasil Hypersil ODS, mobile phase: 0.01 mol/L dipotassium hydrogen phosphate solution (adjusting pH 7.0) -acetonitrile (gradient elution), the flow rate was 1.0 mL/min, the detection wavelength was 290 nm, the temperature was 40 鈩，

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