色标在阿格列汀定量中的应用

Syed Sara Afreen, Durga Panikumar Anumolu, Pulusu Veera Shakar, Ceema Mathew, Devilal Jarpula, Rahul Nalluri
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摘要

两种简单、特异、准确、精密、灵敏且具有成本效益的分光光度法已被开发并验证用于阿格列汀的纯形式和药物制剂的定量。方法一是测定阿格列汀与氯化铁和铁氰化钾反应形成的蓝绿色显色配合物在452nm处的吸光度(氧化还原法)。Method-2是基于MBTH与阿格列汀在氯化铁存在下的氧化偶联反应生成绿色显色剂,在608 nm处最大吸收。方法1和方法2在5 ~ 30µg/ml和20 ~ 100µg/ml浓度范围内均符合比尔定律,相关系数分别为0.9994和0.999。报道了两种分光光度法的检出限、定量限和桑德尔灵敏度值。根据ICH指南对所开发的方法进行了统计验证。在测定过程中,没有观察到常用的辅助药物辅料的显著干扰。采用标准加入法进行回收率试验,进一步确定了两种方法的可靠性。该方法简便、灵敏、专属性好,可用于阿格列汀的常规分析。
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Chromotag application in quantification of alogliptin
Two simple, specific, accurate, precise, sensitive and cost-effective spectrophotometric methods have been developed and validated for quantification of alogliptin in pure form and pharmaceutical formulations. Method 1 is based on the measurement of absorbance of bluish green coloured chromogenic complex at 452 nm which is formed by reaction of alogliptin with ferric chloride and potassium ferricyanide (redox technique). Method-2 is based on the oxidative coupling reaction of MBTH with alogliptin in the presence of ferric chloride to form green coloured chromogen with absorption maximum at 608 nm. The methods obeyed Beer’s law in concentration range of 5-30 µg/ml and 20-100 µg/ml with good correlation coefficients of 0.9994 and 0.999 for method 1 and 2 respectively. The limit of detection, limit of quantification and sandell’s sensitivity values are reported for all the two spectrophotometric methods. The developed method was validated statistically as per ICH guidelines. No significant interference was observed from the excipients commonly used as pharmaceutical aids with the assay procedure. The reliability of both the methods is further ascertained by performing recovery tests by standard addition method. The developed method is simple, sensitive, specific and can be successfully employed in routine analysis of alogliptin in pharmaceutical dosage forms.
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