Abstract

Giri Prasad Gorumutchu¹, Venkata Nadh Ratnakaram*² and Kishore V. N. V³

DOI : http://dx.doi.org/10.13005/ojc/350226

A visible spectrophotometric method was developed and validated for the determination of gemigliptin present in bulk drug and tablet formulation. It involves an indirect method of charge transfer complex formation in presence of NBS, metol and suphanilic acid. Gemigliptin was subjected to oxidation with excess amount of oxidant (NBS) and the unconsumed NBS oxidizes metol to give p-N-methylbenzoquinone monoamine (PNMM) which in turn forms a charge transfer complex with sulphanilic acid. Then validated the above developed method as per the current ICH guidelines. An excellent correlation coefficient (> 0.999) was found for the obtained regression equation (y = –0.0302x + 0.928) in the range of 2.0–30.0 μg mL^-1. The method was found to be simple and rapid because it does not involve any solvent extraction. The recovery levels of the drug were in the range 99.92 – 100.08.

Charge Transfer Complex; Determination; Gemigliptin; Metol; Validation

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