Aim: The aim is to develop and validate a single quantitative method for all DPP-IV inhibitors
(Alogliptin, Vildagliptin, Sitagliptin, Saxagliptin, and Linagliptin).
Background: Metformin is the most used antihyperglycemic drug in diabetes, therefore it is preferred
to be combined with other classes of antihyperglycemic drugs, specially gliptins. Formulating
these two drug classes in one pharmaceutical dosage form would be more efficacious to control
hyperglycemia than having either drug alone.
Objective: This study was designed and performed to develop a new, simple, and reliable method
of analysis for assaying simultaneously five types of gliptins (Alogliptin, Linagliptin, Saxagliptin,
Sitagliptin, and Vildagliptin) and Metformin, which has not been documented before.
Methods: The present method was carried out using a C18 column (250x4.6 mm), 5μm particle
size, mobile phase consisting of water to acetonitrile ratio 85:15% (v/v) and the pH was set by orthophosphoric
acid at 3, 10 μl injection volume, 0.5 ml flow rate, 25oC temperature, and the eluent
was monitored at 232 nm.
Results: The assay's selectivity showed no interference with inactive ingredients in the formulation,
and the %recovery from each drug dosage forms at three different concentrations were within
the acceptable limits of the ICH guidelines. Although the method showed robustness towards the
flow rate, it showed significant change at 230 or 234 nm.
Conclusion: The present analytical method is comprehensive and universal for measuring the five
drugs and Metformin. Such an analytical method can be applied to the present available combined
drug dosage forms of Metformin and one type of gliptins and the possible future of triple combinations
of two gliptins and Metformin.