Quantification of Saxagliptin Hydrochloride in Human Plasma and Dosage Forms by HPLC-MS/MS Method and Its Application to a Bioequivalence Study
Received Date: Feb 08, 2021 / Accepted Date: Feb 20, 2021 / Published Date: Feb 27, 2021
Abstract
Saxagliptin is an orally active, highly potent, selective and competitive dipeptidyl peptidase (DPP)-4 inhibitor used in the treatment of type 2 diabetes mellitus at doses of 2.5 or 5 mg once daily. The purpose of this study was to evaluate the bioequivalence and to investigate the pharmacokinetic properties of two formulations containing 5 mg saxagliptin in 30 healthy Egyptian volunteers. The two formulations were: A: Saxaliza 5 mg film coated tablets, manufactured by Hochster pharmaceutical industries(Egypt) and B: Onglyza 5 mg tablets, manufactured by AstraZeneca pharmaceuticals (USA). All these necessitate the need for a biometric tool to prove the drug pharmaceutical equivalence or bioequivalence.
Citation: Salem H, Badr K (2021) Quantification of Saxagliptin Hydrochloride in Human Plasma and Dosage Forms by HPLC-MS/MS Method and Its Application to a Bioequivalence Study. Clin Pharmacol Biopharm 10: 212.
Copyright: © 2021 Salem H, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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