高效液相色谱法测定过氧化碳酰胺中枸橼酸含量  

Content Determination of Citric Acid in Carbamide Peroxide by HPLC

作　　者：林新文 唐闪光 武欣倩 朱光冕 李颖 海乐 LIN Xinwen;TANG Shanguang;WU Xinqian;ZHU Guangmian;LI Ying;HAI Le(Hunan Provincial Drug Examination and Inspection Center,Changsha,Hunan,China 410001;Hunan Yige Pharmaceutical Co.,Ltd.,Xiangtan,Hunan,China 411100)

机构地区：[1]湖南省药品审核查验中心,湖南长沙410001 [2]湖南一格制药有限公司,湖南湘潭411100

出　　处：《中国药业》2022年第18期76-78,共3页China Pharmaceuticals

摘　　要：目的建立测定过氧化碳酰胺中枸橼酸含量的高效液相色谱法。方法色谱柱为Kromasil 100-5-C_(18)柱(250 mm×4.6 mm,5μm),流动相为乙腈(以三乙胺调pH至7.0)-0.05 mol/L磷酸二氢铵(梯度洗脱),流速为0.7 mL/min,检测波长为210 nm,柱温为25℃,进样量为20μL。结果枸橼酸质量浓度在10.11~404.48μg/mL范围内与峰面积线性关系良好;精密度、稳定性、重复性试验结果的RSD均小于2.0%;平均加样回收率为99.43%,RSD为2.10%(n=9);在流速及流动相pH发生一定程度改变时,该方法能满足试验要求。结论所建立的方法操作简便、专属性强、灵敏度高、重复性及耐用性较好,可用于过氧化碳酰胺中枸橼酸的含量控制。Objective To establish a high-performance liquid chromatography(HPLC)method for the content determination of citric acid in carboxamide peroxide.Methods The chromatographic column was Kromasil 100-5-C_(18) column(250 mm×4.6 mm,5μm),the mobile phase was phosphate acetonitrile(adjusted to pH 7.0 with triethylamine)-0.05 mol/L ammonium dihydrogen with gradient elution,the flow rate was 0.7 mL/min,the detection wavelength was 210 nm,the column temperature was 25℃,and the injection volume was 20μL.Results The linear range of citric acid was 10.11-404.48μg/mL.The RSDs of precision,stability and repeatability tests were all less than 2.0%.The average recovery of citric acid was 99.43%with an RSD of 2.10%(n=9).When the flow rate and pH of the mobile phase changed within a certain range,the method could meet the test requirements.Conclusion The established method is simple,specific,sensitive,reproducible and durable,which can be used for the content control of citric acid in carboxamide peroxide.

关 键 词：过氧化碳酰胺 枸橼酸 高效液相色谱法 含量测定 

分 类 号：R917[医药卫生—药物分析学] R927[医药卫生—药学]