摘要
目的:采用高效液相色谱法建立羧甲基交联淀粉止血颗粒中氯乙酸残留量的质量控制方法。方法:采用C_(8)-3(5μm,4.6 mm×250 mm)色谱柱,以乙腈:pH值2.75磷酸水溶液(体积比2∶98)为流动相,流速0.8 mL/min,检测波长为214 nm,柱温40℃,进样量为20μL。结果:氯乙酸在0.802~6.02μg/mL内具有良好的线性关系,Y=1020X+44.429(R^(2)=0.9998)。定量限和检测限分别为0.502μg/mL和0.161μg/mL。回收率为96.7%(n=9),回收率良好。样品中氯乙酸的残留量小于0.805μg/g。结论:该方法重现性好,简单准确,能有效检测止血颗粒中氯乙酸的残留量。
Objective:To establish a quality control method for determination of monochloroacetic acid residues in hemostatic granules by high performance liquid chromatography(HPLC).Methods:A C_(8)-3 column of 4.6 mm×250 mm,5μm was used and the mobile phase consisted of acetonitrile:phosphoric acid solution at pH 2.75(2∶98).The flow rate was 0.8 mL/min.The detection wavelength was 214 nm.The column temperature was 40℃.And the injection volume was 20μL.Results:The monochloroacetic acid was showed a good linearity in the range of 0.802~6.02μg/mL,Y=1020X+44.429(R^(2)=0.9998).The detection limit is 0.502μg/mL and the quantitative limit is 0.161μg/mL.The average recovery is 96.7%(n=9).The monochloroacetic acid residues in the samples was less than 0.805μg/g.conclusion:The method is scientific,accurate and simple which can effectively detect the residues of monochloroacetic acid in the hemostatic powder.
作者
朱小敏
孟建文
朱肖杰
张素文
罗西友
Zhu Xiaomin;Meng Jianwen;Zhu Xiaojie;Zhang Suwen;Luo Xiyou(Shandong Academy of Pharmaceutical Science,Key Laboratory of Biomedical Polymer,Jinan 250101,China)
出处
《山东化工》
CAS
2022年第10期132-134,共3页
Shandong Chemical Industry
关键词
羧甲基交联淀粉
止血颗粒
高效液相色谱法
氯乙酸残留
carboxymethyl starch
hemostatic granules
high performance liquid chromatography(HPLC)
monochloroacetic acid residues
