Author(s): Monika P. Jadhao*, Madhuri D. Game, Vikram H. Dange
Quality by Design (QbD) is a philosophy that refines the level of knowledge associated with a product that uses process understanding to deliver a product with the desired critical quality attributes. The variables are studied using the design expert software version 10. The objective of this study was to develop an integrated multivariate QbD approach to develop and quantify the constituent concentrations of teneligliptin hydrobromide (TNG) drug in its pure and formulated forms. To facilitate studies investigating the determination of TNG in pure drug and its pharmaceutical formulations, a HPLC method was developed and validated for the determination of TNG. The method fulfilled validation criteria and was shown to be sensitive, with limits of detection (LOD) and quantitation (LOQ) of 0.956 ug/ml and 0.171 ug/ml, respectively. The percentage standard deviation for repeatability, intraday and interday precision was observed is 1.83,1.08 and 1.64. The calibration graph was linear in the range of 10 -50 ul/ml at 247nm. The proposed method can be used for routine analysis in quality control laboratories for its bulk and formulated product and this is the first reported HPLC method for the assay of TNG.