Novel extractive visible spectrophotometric method for determination of antihypertensive drug irbesartan with sulfonephthalein acid dyes in tablets

Ashour Safwan, Bayram Roula
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Abstract

Irbesartan (IRB) is one of the drugs used for the treatment of hypertension. The present work develops and validates two methods for the evaluation of irbesartan in bulk and tablets. Sulfonephthalein acid dyes, bromophenol blue (BPB), and bromocresol purple (BCP) were used to produce stable yellow ion-association complexes with the basic drug IRB in dry chloroform. The colored products are quantified spectrophotometrically at their corresponding λmax. The relation between the absorbed signal and the drug concentration was linear up to 45.0 μg mL-1 (n = 6, r ≥ 0.9998). LOD reaches 40 ng mL-1. The composition of the ion associates was found 1:1 by Job’s and mole ratio methods. Application of the suggested methods to dosage forms is presented with percentage recoveries ranging from 99.33% to 101.67%. The results of the analysis were validated statistically and compared with the official method. No interference was observed from common pharmaceutical adjuvants.
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磺胺酞酸染料提取可见分光光度法测定降压药厄贝沙坦片剂的含量
厄贝沙坦(Irbesartan, IRB)是治疗高血压的药物之一。本研究建立并验证了厄贝沙坦原料药和片剂的两种评价方法。用磺苯酞酸染料、溴酚蓝(BPB)和溴甲酚紫(BCP)与碱性药物IRB在干氯仿中生成稳定的黄色离子缔合物。在相应的λmax处对有色产物进行分光光度定量。在45.0 μg mL-1范围内,吸收信号与药物浓度呈线性关系(n = 6, r≥0.9998)。LOD达到40 ng mL-1。通过约伯比和摩尔比法,发现离子缔合物的组成为1:1。该方法适用于制剂,回收率为99.33% ~ 101.67%。对分析结果进行了统计验证,并与官方方法进行了比较。无常见药物佐剂干扰。
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