Abstract

REVIEW ON ANALYTICAL METHODS DEVELOPMENT AND VALIDATION OF LINAGLIPTIN AS AN ANTIDIABETIC AGENT

Nir D. Solanki*, Krupal J. Chaudhary, Manisha M. Parmar, Het R. Soni, Dr. Khushbu

Abstract

Diabetes mellitus significantly impacts global health, accounting for millions of deaths annually. The development of Dipeptidyl peptidase-4 (DPP-4) inhibitors, particularly linagliptin, offers a promising therapeutic pathway for managing type 2 diabetes. Linagliptin is distinguished by its unique non-renal elimination route, ensuring consistent dosing without adjustment for patients with renal impairment. The aim of this work is to study the pharmacological profile of linagliptin and review the various analytical methods used for its estimation in bulk and pharmaceutical formulations. This paper systematically reviews existing analytical techniques, including UV-Visible Spectroscopy, High-Performance Liquid Chromatography (HPLC), High-Performance Thin-Layer Chromatography (HPTLC), and Liquid Chromatography-Mass Spectrometry (LC-MS). Furthermore, it highlights method development strategies and validation parameters aligned with international regulatory guidelines.

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