高效液相色谱法测定葡萄糖酸氯己定溶液主成分及有关物质含量  

Determination of Principal Component and Related Substances in Chlorhexidine Gluconate Solution by HPLC

作　　者：王发 崔平 庄瑜瑜 李继 刘雪峰 乔荣霞 WANG Fa;CUI Ping;ZHUANG Yuyu;LI Ji;LIU Xuefeng;QIAO Rongxia(Shaanxi Institute for Food and Drug Control,Xi′an,Shaanxi,China 710065)

机构地区：[1]陕西省食品药品检验研究院,陕西西安710065

出　　处：《中国药业》2024年第24期70-73,共4页China Pharmaceuticals

基　　金：陕西省重点研发计划项目[2021SF-304]。

摘　　要：目的建立测定葡萄糖酸氯己定溶液主成分及有关物质含量的高效液相色谱法。方法色谱柱为Capcell PAK C18柱(250 mm×4.6 mm,5μm),流动相为辛烷磺酸钠溶液-乙腈(梯度洗脱),流速为1.0 mL/min,检测波长为254 nm,柱温为35℃,进样量为20μL。结果葡萄糖酸氯己定和特定杂质对氯苯胺质量浓度分别在0.050~0.15 mg/mL和0.0010~0.010 mg/mL范围内与峰面积线性关系良好(r=0.9998,0.9999),定量限分别为0.7和0.5μg/mL,检测限分别为0.3和0.2μg/mL;精密度、稳定性、重复性试验结果的RSD均小于2.0%;平均加样回收率分别为99.50%和101.71%,RSD分别为0.45%和0.92%(n=6);3批样品中葡萄糖酸氯己定和对氯苯胺平均含量分别为20.33%和0.11%,平均杂质总量为2.20%。结论所建方法操作简便,精密度、稳定性、重复性良好,可用于葡萄糖酸氯己定溶液主成分及有关物质的含量测定。Objective To establish a high-performance liquid chromatography(HPLC)method for determining the principal component and related substances in Chlorhexidine Gluconate Solution.Methods The chromatographic column was the Capcell PAK C18 column(250 mm×4.6 mm,5μm),the mobile phase was sodium octanesulfonate solution-acetonitrile(gradient elution),the flow rate was 1.0 mL/min,the detection wavelength was 254 nm,the column temperature was 35℃,and the injection volume was 20μL.Results The linear ranges of chlorhexidine gluconate and specific impurity p-chloroaniline were 0.050-0.15 mg/mL and 0.0010-0.010 mg/mL(r=0.9998,0.9999)respectively.The limits of quantification of the above two components were 0.7,0.5μg/mL,and the limits of detection were 0.3,0.2μg/mL respectively.The RSDs of precision,stability and repeatability tests were all lower than 2.0%.The average recovery rates of the above two components were 99.50%and 101.71%with RSDs of 0.45%and 0.92%(n=6)respectively.The average contents of chlorhexidine gluconate and p-chloroaniline in three batches of samples were 20.33%and 0.11%respectively,with an average total impurity of 2.20%.Conclusion The established method is easy,precise,stable and repeatable,which can be used for the determination of principal component and related substances in Chlorhexidine Gluconate Solution.

关 键 词：高效液相色谱法 葡萄糖酸氯己定 有关物质 含量测定 

分 类 号：R917[医药卫生—药物分析学] R927[医药卫生—药学]