·1301·药品评价DrugEvaluation2022,19（21）HPLC-DAD法测定复方鲜竹沥液中9种防腐剂含量刘艳梅，许妍，张静，洪挺江西省药品检验检测研究院，国家药品监督管理局中成药质量评价重点实验室，江西省药品与医疗器械质量工程技术研究中心，江西南昌330029［摘要］目的：建立高效液相色谱-二极管阵列检测器法（HPLC-DAD）同时测定复方鲜竹沥液中9种防腐剂的含量。方法：选择C18色谱柱，以甲醇为流动相A，以0.02mol/L乙酸铵溶液为流动相B，梯度洗脱；苯甲酸和脱氢乙酸检测波长为230nm，山梨酸和羟苯酯类检测波长为256nm；柱温为30℃。结果：9种防腐剂成分分离效果良好，在考察浓度范围呈良好线性关系（r≥0.9999）；加样回收率（n=6）为92.2%~100.8%，RSD为0.2%~1.3%；102批样品的防腐剂使用均符合标准规定。结论：该方法准确可靠，重复性、耐用性较好，可用于复方鲜竹沥液中防腐剂的筛查和定量测定。［关键词］防腐剂,药物；高效液相色谱-二极管阵列检测器法；复方鲜竹沥液；筛查与含量测定DOI:10.19939/j.cnki.1672-2809.2022.21.06Determinationof9PreservativesinFufangXianzhuliYebyHPLC-DADLIUYanmei,XUYan,ZHANGJing,HONGTingJiangxiInstituteforDrugControl,NMPAKeyLaboratoryofQualityEvaluationofTraditionalChinesePatentMedicine,JiangxiProvinceEngineeringResearchCenterofDrugandMedicalDeviceQuality,NanchangJiangxi330029,China.[Abstract]Objective:ToestablishaHPLC-DADdetectionmethodforsimultaneousdeterminationofninepreservativesinfufangxianzhuliye.Methods:C18columnwasselected,withmethanolasmobilephaseAand0.02mol/LammoniumacetatesolutionasmobilephaseB,andgradientelutionwasperformed;thedetectionwavelengthofbenzoicacidanddehydroaceticacidwas230nm,andthedetectionwavelengthofsorbicacidandhydroxyphenylesterswas256nm;columntemperaturewas30℃.Results:Ninepreservativeswerewellseparatedandshowedagoodlinearrelationshipintheirrespectiveconcentrationranges(r≥0.9999);therecoveryrate(n=6)was92.2%-100.8%,RSDwas0.2%-1.3%;theuseofpreservativesin102batchesofsamplesmetthestandardrequirements.Conclusion:Themethodisaccurate,reliable,repeatableanddurable,andcanbeusedforscreeningandquantitativedeterminationofpreservativesinfufangxianzhuliye.[KeyWords]Preservatives,medicine;HP...
