·32·药品评价DrugEvaluation2024,21（1）复方氨酚烷胺片质量标准研究何倌发1,2，李春华1，彭会娟1，艾珊1，周结祥1，张珊珊11.抚州市检验检测认证中心，江西抚州344000；2.江西省药品检查员中心，江西南昌330029摘要：目的完善复方氨酚烷胺片的质量标准，提高质量标准的质量控制水平。方法建立HPLC法测定杂质对氨基酚的含量；建立HPLC法同时测定对乙酰氨基酚、咖啡因和马来酸氯苯那敏的含量；建立HPLC法同时测定咖啡因和马来酸氯苯那敏的含量均匀度。结果所建立的HPLC法测定对氨基酚杂质、含量均匀度及含量测定的方法，其线性关系均良好，准确可靠，重复性较好。按拟定的标准，19批次复方氨酚烷胺片样品中有1批次样品咖啡因含量测定项目不符合规定，有1批次样品咖啡因含量均匀度项目不符合规定。结论本研究提高和完善了复方氨酚烷胺片的质量控制项目，为更全面控制复方氨酚烷胺片的质量提供方法和参考。关键词：质量控制；复方氨酚烷胺片；杂质；含量测定；含量均匀度DOI:10.19939/j.cnki.1672-2809.2024.01.07StudyontheQualityStandardofCompoundParacetamolandAmantadineHydrochlorideTabletsHEGuanfa1,2,LIChunhua1,PENGHuijuan1,AIShan1,ZHOUJiexiang1,ZHANGShanshan11.FuzhouInspection&TestingCertificationCenter,FuzhouJiangxi344000,China;2.JiangxiDrugInspectionCenter,NanchangJiangxi330029,China.Abstract:ObjectiveToperfectthequalitystandardofcompoundparacetamolandamantadinehydrochloridetabletsandimprovethequalitycontrollevelofthequalitystandard.MethodsTheHPLCmethodwasestablishedforp-aminophenolimpurities,thesimultaneousdeterminationofparacetamol,caffeineandchlorpheniramine.TheHPLCmethodwasestablishedforthesimultaneousdeterminationofparacetamol,caffeineandchlorpheniramine,andtheHPLCmethodwasestablishedforthesimultaneousdeterminationofthecontentuniformityofcaffeineandchlorpheniramine.ResultsTheestablishedHPLCmethodforthedeterminationofimpurities,contentandcontentuniformityhasgoodlinearrelationship,accuracy,reliabilityandrepeatability.Accordingtotheproposedstandards,in19batchesofsamples,thecontentofcaffeineinonebatchexceededthestandardrange,andthecontentuniformityofcaffeineinonebatchexceededthestandardrange.ConclusionThisstudyimprovedandperfectedtheq...
