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分光光度法测定某些组胺H1拮抗剂药物在其制剂中的含量。

Spectrophotometric determination of some histamine H1-antagonists drugs in their pharmaceutical preparations.

作者信息

Hassan Wafaa S, El-Henawee Magda M, Gouda Ayman A

机构信息

Analytical Chemistry Department, Faculty of Pharmacy, Zagazig University, Zagazig, Egypt.

出版信息

Spectrochim Acta A Mol Biomol Spectrosc. 2008 Jan;69(1):245-55. doi: 10.1016/j.saa.2007.03.040. Epub 2007 Mar 31.

Abstract

Two rapid, simple and sensitive extractive specrophotometric methods has been developed for the determination of three histamine H1-antagonists drugs, e.g., chlorphenoxamine hydrochloride (CPX), diphenhydramine hydrochloride (DPH) and clemastine (CMT) in bulk and in their pharmaceutical formulations. The first method depend upon the reaction of molybdenum(V) thiocyanate ions (Method A) with the cited drugs to form stable ion-pair complexes which extractable with methylene chloride, the orange red color complex was determined colorimetrically at lambda(max) 470nm. The second method is based on the formation of an ion-association complex with alizarin red S as chromogenic reagents in acidic medium (Method B), which is extracted into chloroform. The complexes have a maximum absorbance at 425 and 426nm for (DPH or CMT) and CPX, respectively. Regression analysis of Beer-Lambert plots showed a good correlation in the concentration ranges of 5.0-40 and 5-70microgmL(-1) for molybdenum(V) thiocyanate (Method A) and alizarin red S (Method B), respectively. For more accurate analysis, Ringbom optimum concentration ranges were calculated. The molar absorptivity, Sandell sensitivity, detection and quantification limits were calculated. Applications of the procedure to the analysis of various pharmaceutical preparations gave reproducible and accurate results. Further, the validity of the procedure was confirmed by applying the standard addition technique and the results obtained in good agreement well with those obtained by the official method.

摘要

已开发出两种快速、简单且灵敏的萃取分光光度法,用于测定三种组胺H1拮抗剂药物,即盐酸氯苯那敏(CPX)、盐酸苯海拉明(DPH)和氯马斯汀(CMT)的原料药及其制剂。第一种方法基于钼(V)硫氰酸根离子(方法A)与上述药物反应形成稳定的离子对络合物,该络合物可用二氯甲烷萃取,在470nm波长处比色测定橙红色络合物。第二种方法基于在酸性介质中与茜素红S作为显色剂形成离子缔合络合物(方法B),该络合物被萃取到氯仿中。对于(DPH或CMT)和CPX,络合物分别在425和426nm处有最大吸收。对Beer-Lambert曲线的回归分析表明,钼(V)硫氰酸盐(方法A)和茜素红S(方法B)在浓度范围分别为5.0 - 40和5 - 70μg/mL时具有良好的相关性。为了进行更准确的分析,计算了Ringbom最佳浓度范围。计算了摩尔吸光率、桑德尔灵敏度、检测限和定量限。该方法应用于各种药物制剂的分析,结果具有重现性和准确性。此外,通过标准加入技术证实了该方法的有效性,所得结果与官方方法所得结果吻合良好。

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