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作 者:王鹏 钟振华 刘彭浩邦 陈雨萍 程奇珍 WANG Peng;ZHONG Zhen-hua;LIU Peng-hao-bang;CHEN Yu-ping;CHENG Qi-zhen(Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Jiangxi Nanchang 330029,China;School of Pharmacy of Jiangxi University of Traditional Chinese Medicine,Jiangxi Nanchang 330004,China;Guangdong Pharmaceutical University,Guangdong Guangzhou 510006,China)
机构地区:[1]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 [2]江西中医药大学药学院,江西南昌330004 [3]广东药科大学,广东广州510006
出 处:《中国药物评价》2020年第4期276-278,共3页Chinese Journal of Drug Evaluation
基 金:国家药品标准提高研究项目(食药监办药化管[2017]139号)。
摘 要:目的:建立气相色谱(GC)法测定复方水杨酸樟碘溶液中樟脑、薄荷油和苯酚的含量,为修订现行国家药品标准中的含量测定方法提供参考和依据。方法:采用色谱柱为KB-WAX 30 m×0.530 mm×3.00μm毛细管色谱柱;检测器:FID检测器;进样口温度:220℃;升温程序:初始温度为120℃,维持15 min,以50℃·min^-1的速率升温至220℃,维持15 min;检测器温度:300℃;载气流速:3.0 mL·min^-1;进样体积:1μL。结果:樟脑在0.07517~4.510 mg·mL^-1、薄荷脑在0.00613~0.2453 mg·mL^-1、苯酚在0.07517~4.510 mg·mL-1范围内,线性关系良好(r>0.999)平均回收率分别为99.1%(RSD=0.8%)、99.4%(RSD=1.0%)和99.6%(RSD=0.9%)。结论:本方法灵敏、准确、重现性好,可用于复方水杨酸樟碘溶中樟脑、薄荷油和苯酚的测定。Objective:To establish GC method for determination of Camphor Menthol and Phenol in Compound salicylic acid iodine solution.Methods:GC was used by KB-WAX 30 m×0.530 mm×3.00μm Capillary column.The detector was FID Inlet temperature was 220℃.The temperature program was as follows:the initial column temperature was 120℃,kept for 5min,and then risen to 220℃with a rate of 50℃·min^-1 and kept for 15 min.The detector temperature was 300℃.The follow rate was 3.0 mL·min^-1 and the injection volume was 1μL.Results:The linear equations of Camphor Menthol and Phenol were in good linear range(r>0.999).The average recovery of Camphor Menthol and Phenol was 99.1%(RSD=0.8%)、99.4%(RSD=1.0%)and 99.6%(RSD=0.9%).Conclusion:The method is sensitive and accurate with good stability,which can be used to determine the contents of Camphor、Menthol and Phenol in compound salicylic acid iodine solution.
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