Introduction: Saxagliptin hydrochloride is an oral hypoglycemic agent used for the treatment
of type 2 diabetes mellitus. Saxagliptin is unstable because it undergoes an intra-molecular cyclisation
reaction to form a cyclicamidine in both solution and solid states. In pharmaceutical development of
saxagliptin it is important to select the excipients which are compatible and help to minimize the formation
of cyclicamidine. In excipient compatibility study for saxagliptin it is essential to identify the
formation of cyclicamidine and other related substances.
Materials and Methods: In the current work, the method for quantification of saxagliptin, cyclicamidine
and its related substances by high performance liquid chromatographic was developed and validated.
This method was used as screening technique for assessing the compatibility of saxagliptin with
some pharmaceutical excipients. These were evaluated by analyzing the pure saxagliptin and saxagliptin-
excipient in physical mixture, which were stored under different conditions at 40°C/75% Relative
Humidity (RH) for one month. The method was successfully validated as per ICH guidelines.
Results and Conclusion: The results of compatibility study demonstrate the suitability of saxagliptin
with Methocel, Polyethylene Glycol (PEG), Opadry Red, Opadry pink, Opadry white, and Opadry Pink.