Gliptins represent a dipeptidyl peptidase-4 inhibitors that improve beta cell health and suppress glucagon, leading to improved
post-prandial and fasting hyperglycemia used for the treatment of type 2 diabetes mellitus. A simple and quick approach of stability
indicating RP-HPLC technique was developed for the determination of Metformin, (Met), Saxagliptin (Saxa) and Sitagliptin (Sita)
in bulk and pharmaceutical dosage forms. This projected methodology is apt for the multicomponent estimation of 2 totally
different commercially existing combinations in pharmaceutical market used for the treatment of type II diabetes mellitus viz.
Sitagliptin and metformin, saxagliptin and metformin in 8 min. A chromatographic separation of the three drugs was attained with a
Inertsil C18 (4.6 250 mm, 5 mm) analytical column using a buffer potassium dihydrogen phosphate adjusted pH 4 with ortho-
phosphoric acid: methanol:acetonitrile (70:10:20%v/v) in isocratic mode at a flow rate of mL/min, column at ambient temperature
and detection of each 3 drugs were monitored at 215 nm using a DAD detector. These established techniques were subjected for
forced degradation studies in different stress conditions. This suggested methodology was found to be specific and stability
indicating as no interfering peaks of degradation compounds in forced degradation study and excipients was noticed. The
Robustness study and percentage of the assay of the formulations was established within the limit of ICH guidelines.
© 2015 The Authors. Production and hosting by Elsevier B.V. on behalf of University of Kerbala. This is an open access article
under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Gliptins represent a dipeptidyl peptidase-4 inhibitors that improve beta cell health and suppress glucagon, leading to improved post-prandial and fasting hyperglycemia used for the treatment of type 2 diabetes mellitus. A simple and quick approach of stability indicating RP-HPLC technique was developed for the determination of Metformin, (Met), Saxagliptin (Saxa) and Sitagliptin (Sita) in bulk and pharmaceutical dosage forms. This projected methodology is apt for the multicomponent estimation of 2 totally different commercially existing combinations in pharmaceutical market used for the treatment of type II diabetes mellitus viz. Sitagliptin and metformin, saxagliptin and metformin in 8 min. A chromatographic separation of the three drugs was attained with a Inertsil C18 (4.6 250 mm, 5 mm) analytical column using a buffer potassium dihydrogen phosphate adjusted pH 4 with ortho- phosphoric acid: methanol:acetonitrile (70:10:20%v/v) in isocratic mode at a flow rate of mL/min, column at ambient temperature and detection of each 3 drugs were monitored at 215 nm using a DAD detector. These established techniques were subjected for forced degradation studies in different stress conditions. This suggested methodology was found to be specific and stability indicating as no interfering peaks of degradation compounds in forced degradation study and excipients was noticed. The Robustness study and percentage of the assay of the formulations was established within the limit of ICH guidelines. © 2015 The Authors. Production and hosting by Elsevier B.V. on behalf of University of Kerbala. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
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