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

Abstract

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 (<1225˃) was done on the developed analysis method and calibration curve was plotted successfully with a reasonable R2 equal to 0.9993 and the equation of the curve was Y = 3.4588X +30.099. Then precision, accuracy and robustness of were studied. The mobile phases, column, column temperature, sample preparation solvent as well as detector wave length are different in two methods. It seems that the validated method could be a valuable alternative method for USP method depending on users facilities for analysis. It seems with presenting of this method, more pharmaceutical research center can be able to analysis sitagliptin with high degree of assurance

Keywords

• Sitagliptin Phosphate
• Analytical Method Validation
• Impurities
• assay
• HPLC
• Pharmacopeial analytical method