Spectrophotometric Determination of Alprazolam in Pure and Pharmaceutical Forms using Triphenyl Methane Dyes

V. Nandu, T. Veeraiah
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Abstract

Three simple and sensitive extractive spectrophotometric methods have been described for the assay of Alprazolam either in pure form or in pharmaceutical formulations. The developed methods involve formation of coloured chloroform extractable ion-pair complexes of the drug with bromothymol blue (BTB), bromophenol blue (BPB) and bromocresol green (BCG) in acidic medium. The extracted complexes showed absorbance maxima at 410, 408 and 405nm with use of the cited reagents, respectively. The stoichiometry of the complex is found to be 1:1 in each case. Beer’s law is obeyed in the concentration ranges 3.0-25, 4.0-30, and 4.5-40μg/ml with BTB, BPB and BCG respectively. The effect of concentration of dye, pH, and interference of excipients have been studied and optimized. The limits of detection and quantification have been determined for three methods. All the three methods have been validated as per the guidelines of ICH. The methods have been applied to the determination of drug in commercial tablets and results of analysis were validated statistically through recovery studies.
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三苯甲烷染料分光光度法测定阿普唑仑的纯度和药物含量
本文描述了三种简单灵敏的提取分光光度法测定纯形式或制剂中的阿普唑仑。所开发的方法涉及在酸性介质中与溴百里酚蓝(BTB)、溴酚蓝(BPB)和溴甲酚绿(BCG)形成有色氯仿可提取离子对络合物。所提配合物在410、408和405nm处吸光度最大。在每种情况下,络合物的化学计量都是1:1。BTB、BPB、BCG分别在3.0 ~ 25、4.0 ~ 30、4.5 ~ 40μg/ml范围内符合Beer定律。考察了染料浓度、pH、辅料干扰等因素的影响,并进行了优化。确定了三种方法的检出限和定量限。这三种方法均按照ICH指南进行了验证。将该方法应用于市售片剂中药物含量的测定,并通过回收率研究对分析结果进行了统计验证。
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