Current Trends in Pharmacy and Pharmaceutical Chemistry 2024;6(3):114–121 Content available at: https://www.ipinnovative.com/open-access-journals Current Trends in Pharmacy and Pharmaceutical Chemistry Journal homepage: https://www.ctppc.org/ Original Research Article Comparative in-Vitro dissolution study of some sitagliptin generic tablets under biowaiver conditions by UV-Spectroscopy Vaibhav S. Adhao 1 *, Jaya P. Ambhore 1 , Anant D. Bhuskat 1 , Dishali V. Talokar 1 1 Dept. of Quality Assurance, Dr. Rajendra Gode College of Pharmacy, Malkapur, Maharashtra, India ARTICLE INFO Article history: Received 18-05-2024 Accepted 28-06-2024 Available online 07-09-2024 Keywords: Sitagliptin Dissolution study Biowaiver Antidiabetic Bioequivalence UV spectroscopy ABSTRACT Purpose: The objective of this study is to evaluate the bioequivalence of generic sitagliptin tablets from different manufacturers using in-vitro dissolution study under biowaiver conditions through UV Spectroscopy, and compare them with the innovator brand. Materials and Methods: The dissolution media consisted of three different buffers with varying pH levels, including HCl Buffer pH 2.0, Phosphate Buffer pH 4.0, and Phosphate Buffer pH 7.2. The dissolution process was conducted using a USP type-2 dissolution apparatus with a 900 ml basket. The rotational speed of the paddle was set at 50 RPM, while maintaining a temperature of 37.5 ◦ C +/- 2 ◦ C. Samples were collected at four different intervals as recommended by the USFDA, which were 15, 30, 45, and 60 minutes. Results: Validation parameters such as Accuracy, Precision, Linearity, LOD, and LOQ were assessed. The dissolution profiles exhibited no significant variability between different brands and within the same brand. Furthermore, the dissolution results of all tablet formulations, including the innovator brand, were analysed using the difference factor (f1) and similarity factor (f2). Conclusion: The findings from this study indicate that both generic brands of sitagliptin tablets meet the USFDA dissolution specifications and can be considered interchangeable. This is an Open Access (OA) journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms. For reprints contact: reprint@ipinnovative.com 1. Introduction Approximately 500 million individuals globally suffer with diabetes and diabetes-related deaths account for almost 1.5 million deaths annually. In 2019 there were 1.5 million deaths directly associated with diabetes, with 48% of these deaths happening before the age of 70. 1 The rate of increase in prevalence has been higher in middle-income and low-income countries compared to high-income nations. Diabetes or diabetes mellitus (DM) develops when the pancreas fails to secrete enough insulin or the body is unable to utilize the insulin that is produced to regulate glucose level in body. Apart from alterations in lifestyle, there exist multiple categories of pharmaceutical drugs that decrease * Corresponding author. E-mail address: adhao.vaibhav@gmail.com (V. S. Adhao). blood glucose levels through diverse modes of action. Some of these include insulin, sulfonylureas, thiazolidinediones, biguanides like metformin, meglitinides, insulin agonists like pramlintide, and analogues of glucagon-like peptide-1 (GLP-1) eg, exenatide. The first medication in a novel class that blocks dipeptidyl peptidase-4’s (DPP-4) proteolytic action is sitagliptin. sitagliptin makes strides glycaemic control by hindering DPP-4 inactivation of the incretin hormones glucagon like peptide-1 (GLP-1) and glucose–dependent affront tropic polypeptide (GIP). This represses glucagon discharge from alpha cells and moderates the assimilation of supplements into the blood stream and encourage causes an increment within the sum of affront discharge from beta cells. 2 It was approved by the US FDA for the treatment of type 2 diabetes mellitus in https://doi.org/10.18231/j.ctppc.2024.025 2582-5062/© 2024 Author(s), Published by Innovative Publication. 114