Correlation of results between validated in-house analysis method with new pharmacopeia monograph for analysis of Sitagliptin Phosphate API

Having validated analysis methods for medicinal ingredients is attractive for pharmaceutical companies. When a new molecule is introduced to the market, there is not any pharmacopeial analysis method for that. After publishing official methods, correlation between validated in-house methods and the official one could stablish the value of the in-house method. Sitagliptin phosphate is a new antidiabetic pharmaceutical ingredient and many pharmaceutical companies are trying to manufacture high quality dosage forms with that. In the present study, a full validated in-house method for analysis of sitagliptin phosphate Active Pharmaceutical Ingredient (API) is presented and the method is compared with newly published United State Phrmacopeia (USP) monograph. Results show that the in-house method is correlated with the USP method in regard with assay study and even could separate and detect more probable impurities in the sample. In brief a full analytical method validation based on USP general chapter (