采用胶束液相色谱法分析含抗组胺药的药物制剂。
Analysis of pharmaceutical preparations containing antihistamine drugs by micellar liquid chromatography.
作者信息
Martínez-Algaba C, Bermúdez-Saldaña J M, Villanueva-Camañas R M, Sagrado S, Medina-Hernández M J
机构信息
Departamento de Química Analítica, Universitat de València, C/Vicente Andrés Estellés s/n, E-46100 Burjassot, Valencia, Spain.
出版信息
J Pharm Biomed Anal. 2006 Feb 13;40(2):312-21. doi: 10.1016/j.jpba.2005.07.037. Epub 2005 Sep 22.
Rapid chromatographic procedures for analytical quality control of pharmaceutical preparations containing antihistamine drugs, alone or together with other kind of compounds are proposed. The method uses C18 stationary phases and micellar mobile phases of cetyltrimethylammonium bromide (CTAB) with either 1-propanol or 1-butanol as organic modifier. The proposed procedures allow the determination of the antihistamines: brompheniramine, chlorcyclizine, chlorpheniramine, diphenhydramine, doxylamine, flunarizine, hydroxyzine, promethazine, terfenadine, tripelennamine and triprolidine, in addition to caffeine, dextromethorphan, guaifenesin, paracetamol and pyridoxine in different pharmaceutical presentations (tablets, capsules, suppositories, syrups and ointments). The methods require minimum handling sample and are rapid (between 3 and 12 min at 1 mLmin(-1) flow rate) and reproducible (R.S.D. values<5%). Limits of detection are lower than 1 microgmL(-1) and the recoveries of the analytes in the pharmaceutical preparations are in the range 100+/-10%.
本文提出了用于含抗组胺药的药物制剂分析质量控制的快速色谱方法，这些制剂可以单独含抗组胺药，也可以与其他类型的化合物一起使用。该方法使用C18固定相和十六烷基三甲基溴化铵（CTAB）的胶束流动相，以1-丙醇或1-丁醇作为有机改性剂。所提出的方法可以测定多种抗组胺药：溴苯那敏、氯环利嗪、氯苯那敏、苯海拉明、多西拉敏、氟桂利嗪、羟嗪、异丙嗪、特非那定、曲普利啶和曲吡那敏，此外还能测定不同药物剂型（片剂、胶囊、栓剂、糖浆和软膏）中的咖啡因、右美沙芬、愈创甘油醚、对乙酰氨基酚和维生素B6。这些方法所需的样品处理最少，速度快（在流速为1 mLmin(-1)时，分析时间在3至12分钟之间）且具有重现性（相对标准偏差值<5%）。检测限低于1 microgmL(-1)，药物制剂中分析物的回收率在100±10%范围内。
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