【摘要】：目的:建立測(cè)定注射用泮托拉唑鈉中有關(guān)物質(zhì)的方法。方法:采用高效液相色譜法。色譜柱為Kromasil Hypersil ODS,流動(dòng)相為0.01 mol/L磷酸氫二鉀溶液(調(diào)節(jié)pH為7.0)-乙腈(梯度洗脫),流速為1.0 mL/min,檢測(cè)波長(zhǎng)為290 nm,柱溫為40℃,進(jìn)樣量為20μL。結(jié)果:雜質(zhì)A、B、C+E、D檢測(cè)質(zhì)量濃度線性范圍分別為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);定量限分別為0.834、0.780、1.556、0.794ng/mL,檢測(cè)限分別為0.417、0.390、0.778、0.397 ng/mL;精密度試驗(yàn)的RSD1.0%,重復(fù)性試驗(yàn)中總雜質(zhì)峰面積的RSD1.0%;回收率分別為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)。結(jié)論:該方法簡(jiǎn)便、準(zhǔn)確,可用于注射用泮托拉唑鈉中有關(guān)物質(zhì)的測(cè)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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