Hussein S A, El-Kommos M E, Hassan H Y, Mohamed A M
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Assiut University, Assiut, Egypt.
Talanta. 1989 Sep;36(9):941-4. doi: 10.1016/0039-9140(89)80034-7.
Two sensitive spectrophotometric methods for the determination of imipramine hydrochloride, clomipramine hydrochloride, desipramine hydrochloride, and trimipramine maleate in bulk and in dosage forms are described. The first method is based on the interaction of diazotized p-nitroaniline (DPNA) with the dibenzazepine drug in 5M hydrochloric acid. The second is based on the oxidative coupling of the dibenzazepine drug with 3-methylbenzothiazolin-2-one hydrazone (MBTH) in the presence of ammonium iron(III) sulphate in 0.1M hydrochloric acid. The resulting chromophores are measured at 575 nm (for the DPNA method) or at 620-630 nm (for the MBTH method), and are stable for at least 24 hr. The commonly encountered excipients and additives do not interfere with the determinations. Results from the analysis of pure drugs, commercial tablets and laboratory-prepared tablets by these methods agree well with those of official methods.
本文描述了两种灵敏的分光光度法,用于测定原料药及制剂中的盐酸丙咪嗪、盐酸氯米帕明、盐酸地昔帕明和马来酸三甲丙咪嗪。第一种方法基于重氮化对硝基苯胺(DPNA)与二苯并氮䓬类药物在5M盐酸中的相互作用。第二种方法基于二苯并氮䓬类药物在0.1M盐酸中硫酸铁(III)铵存在下与3-甲基苯并噻唑啉-2-酮腙(MBTH)的氧化偶联反应。在575nm(DPNA法)或620 - 630nm(MBTH法)处测量生成的发色团,且至少在24小时内稳定。常见的辅料和添加剂不干扰测定。用这些方法对纯药物、市售片剂和实验室制备片剂进行分析的结果与官方方法的结果吻合良好。