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首页> 美国卫生研究院文献>Journal of Pharmaceutical Analysis >Novel and validated titrimetric method for determination of selected angiotensin-II-receptor antagonists in pharmaceutical preparations and its comparison with UV spectrophotometric determination
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Novel and validated titrimetric method for determination of selected angiotensin-II-receptor antagonists in pharmaceutical preparations and its comparison with UV spectrophotometric determination

机译：新型验证滴定法测定药物制剂中选定的血管紧张素II受体拮抗剂及其与紫外分光光度法的比较

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摘要

A novel and simple titrimetric method for determination of commonly used angiotensin-II-receptor antagonists (ARA-IIs) is developed and validated. The direct acid base titration of four ARA-IIs, namely eprosartan mesylate, irbesartan, telmisartan and valsartan, was carried out in the mixture of ethanol:water (1:1) as solvent using standardized sodium hydroxide aqueous solution as titrant, either visually using phenolphthalein as an indicator or potentiometrically using combined pH electrode. The method was found to be accurate and precise, having relative standard deviation of less than 2% for all ARA-IIs studied. Also, it was shown that the method could be successfully applied to the assay of commercial pharmaceuticals containing the above-mentioned ARA-IIs. The validity of the method was tested by the recovery studies of standard addition to pharmaceuticals and the results were found to be satisfactory. Results obtained by this method were found to be in good agreement with those obtained by UV spectrophotometric method. For UV spectrophotometric analysis ethanol was used as a solvent and wavelength of 233 nm, 246 nm, 296 nm, and 250 nm was selected for determination of eprosartan mesylate, irbesartan, telmisartan, and valsartan respectively. The proposed titrimetric method is simple, rapid, convenient and sufficiently precise for quality control purposes.
机译：开发并验证了一种新颖，简单的滴定法测定常用的血管紧张素II受体拮抗剂（ARA-IIs）。在乙醇：水（1：1）的混合物中，使用标准化的氢氧化钠水溶液作为滴定剂，对四种ARA-II的直接酸碱滴定在乙醇：水（1：1）的溶剂中进行酚酞作为指示剂或电位计使用组合pH电极。发现该方法是准确和精确的，对于所有研究的ARA-II，其相对标准偏差均小于2％。而且，表明该方法可以成功地用于测定含有上述ARA-II的商业药物。该方法的有效性通过对药物中标准添加物的回收率研究进行了测试，结果令人满意。发现通过该方法获得的结果与通过紫外分光光度法获得的结果非常一致。对于紫外分光光度分析，使用乙醇作为溶剂，分别选择233 nm，246 nm，296 nm和250 nm的波长分别测定甲磺酸依普罗坦，厄贝沙坦，替米沙坦和缬沙坦。所提出的滴定法简单，快速，方便并且足够精确以用于质量控制。

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