Abstract

Giri Prasad Gorumutchu¹, Venkata Nadh Ratnakaram² and Sireesha Malladi³

DOI : http://dx.doi.org/10.13005/ojc/350145

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 (Ruhemenn’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.

Determination; Gemigliptin; Ninhydrin; Ruhemenn’s Purple; Validation

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