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高效液相色谱法和导数分光光度法对药物制剂中阿伐斯汀和盐酸伪麻黄碱的定量测定

Quantitative determination of acrivastine and pseudoephedrine hydrochloride in pharmaceutical formulation by high performance liquid chromatography and derivative spectrophotometry.

作者信息

Altuntas T G, Zanooz S S, Nebioglu D

机构信息

Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Ankara, Tandogan, Turkey.

出版信息

J Pharm Biomed Anal. 1998 May;17(1):103-9. doi: 10.1016/s0731-7085(97)00148-9.

DOI:10.1016/s0731-7085(97)00148-9
PMID:9608432
Abstract

In this study, fourth derivative spectrophotometry and high performance liquid chromatography (HPLC) have been used and described for the quantitative determination of acrivastine (I) and pseudoephedrine hydrochloride (II) in their pharmaceutical capsules form (Duact). In the former method, d4A/d gamma 4 values were measured in methanol at 315 and 269 nm for (I) and (II) respectively. The relative standard deviations (RSD) for the method were found to be 1.16% for (I) and 0.94% for (II). The latter method based on reversed phase HPLC system using LiChrosorb C18 analytical column. The mobile phase used for separation of (I), (II) and internal standard (p-hydroxymethylbenzoate) were the water/acetonitrile/methanol/perchloric acid/n-octylamine (500:130:25:13:0.3 v/v) and the detection of the compounds in the capsules were at 260 nm using UV detector. The RSD for the HPLC method were determined to be 0.79 and 0.88% for (I) and (II) respectively. The proposed methods, which give thoroughly comparable data, are simple, rapid, and allow precise and accurate results and could be used for commercial formulations containing acrivastine and pseudoephedrine hydrochloride in combination.

摘要

在本研究中,已采用并描述了四阶导数分光光度法和高效液相色谱法(HPLC)用于定量测定阿伐斯汀(I)和盐酸伪麻黄碱(II)的药用胶囊制剂(Duact)。在前一种方法中,分别在甲醇中于315和269 nm处测定(I)和(II)的d4A/dγ4值。该方法的相对标准偏差(RSD)对于(I)为1.16%,对于(II)为0.94%。后一种方法基于使用LiChrosorb C18分析柱的反相HPLC系统。用于分离(I)、(II)和内标(对羟基甲基苯甲酸酯)的流动相为水/乙腈/甲醇/高氯酸/正辛胺(500:130:25:13:0.3 v/v),使用紫外检测器在260 nm处检测胶囊中的化合物。HPLC方法的RSD对于(I)和(II)分别确定为0.79%和0.88%。所提出的方法给出了完全可比的数据,简单、快速,能得到精确准确的结果,可用于含有阿伐斯汀和盐酸伪麻黄碱组合的商业制剂。

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