Chromotag application in quantification of alogliptin

Abstract

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.