Ninhydrin Based Visible Spectrophotometric Determination of Gemigliptin

What is it about?

A simple method is described to determine the amount of gemigliptin in bulk and tablet formulation by visible spectrophotometry. Basis of the proposed method is the reaction of the primary amine present on gemigliptin with ninhydrin in alkaline pH (alkaline borate buffer) medium to produce a purple color (Ruhemann’s purple) which has maximum absorption at 558 nm. The method was validated as per the current ICH guidelines. The obtained regression equation (y = 0.0148x+0.0011) in the range of 5-30 μg mL-1 has a good correlation coefficient (> 0.999). As the method does not require any separation, it is rapid and simple. The recovery levels of the drug were in the range of 99.73 – 99.96. This method is a green method as it no organic solvents were employed.

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Why is it important?

Formation of a purple color (Ruhemann’s purple) is due to the reaction between primary amine present on gemigliptin and ninhydrin in alkaline pH medium. As organic solvents are avoided in the present method, it can be considered as a green method. The proposed method was validated as per the existing guidelines of ICH. As alternative to the expensive instrumental methods, this method can be considered for routine analysis of gemigliptin (bulk drug and tablet formulation) in quality control laboratories.

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