UV Spectrophotometric Method Development and Validation of Teneligliptin Hydrobromide Hydrate in Bulk and Marketed Brand and Generic Tablet Dosage Form

A Simple, sensitive, precise, rapid and economical UV Spectrophotometric method for determining Teneligliptin Hydrobromide Hydrate (THH) in both bulk and various marketed tablet dosage forms was developed and validated. The standard solutions of Teneligliptin Hydrobromide Hydrate (THH) were prepared using Distilled water. The standard solution of THH showed maximum absorption (λ max) at wavelength 244nm. This method obeys Beer’s law in the concentration range from 10-50μg/ml. The regression of the curve was found Y=0.00182x+0.0096 and the correlation coefficient was found to be 0.9994. The developed method was applied to marketed brand and generic tablet dosage forms and the % amount of drug estimated was 101.33% and 102% respectively. It was in accordance with the label claim. The Accuracy was found to be 97.7%. The limit of detection and limit of quantification was found to be 0.5439µg/ml and 1.648µg/ml respectively. Precision studies were performed as intraday and interday variations %RSD value within the limit of ≤ 2. The ICH guidelines were followed in the development and validation of the method. This method was simple, rapid and economical for the routine analysis of Teneligliptin Hydrobromide Hydrate (THH) in bulk and pharmaceutical dosage forms.