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目的:建立去甲斑蝥酸钠注射液含量HPLC及有关物质的测定方法。方法:以C18柱,0.1mol·L-1磷酸氢二钾溶液-乙腈(80:20)(磷酸调节pH值至2.6)为流动相,流量为1.0ml·min-1,柱温30℃。检测波长为210nm。结果:在浓度为20.00～200.04μg·mL-1范围内,本法线形关系良好,相关系数r=0.9997(n=7)。结论:该方法简单,准确,可以作为去甲斑蝥酸钠注射液含量和有关物质的测定方法。
Objective: To establish a HPLC method for the determination of sodium norcantharidate injection and its related substances. Methods: The mobile phase consisted of C18 column, 0.1 mol·L-1 dipotassium hydrogen phosphate solution (80:20) and phosphoric acid (pH = 2.6). The flow rate was 1.0 ml · min-1 and the column temperature was 30 ℃. The detection wavelength is 210nm. Results: In the range of 20.00 ~ 200.04μg · mL-1, the linear relationship of this method was good with a correlation coefficient of r = 0.9997 (n = 7). Conclusion: The method is simple and accurate and can be used as a method for determination of the content and related substances of nornicarbanthacin sodium injection.