Abstract

REVIEW OF ANALYTICAL TECHNIQUES FOR SIMULTANEOUS ESTIMATION OF PIOGLITAZONE HYDROCHLORIDE AND VILDAGLIPTIN IN PHARMACEUTICAL FORMULATIONS

Manthan Oza*, Dr. Khushbu Patel, Mrs. Khushbu S. Patel, Jinal Goswami, Dr. C. N.

Abstract

Diabetes mellitus is a chronic metabolic disorder characterized by persistently elevated blood glucose levels due to defects in insulin secretion, insulin action, or both. Based on etiology and pathophysiology, diabetes mellitus is broadly classified into Type 1 and Type 2 diabetes mellitus. Type 1 diabetes results from autoimmune destruction of pancreatic β-cells, leading to absolute insulin deficiency and requiring lifelong insulin therapy. In contrast, Type 2 diabetes mellitus is primarily associated with insulin resistance and relative insulin deficiency and is commonly managed using oral antidiabetic agents, with or without insulin. Pioglitazone hydrochloride and vildagliptin are widely prescribed oral antidiabetic drugs used either alone or in combination for the management of Type 2 diabetes mellitus. The present work focuses on the development and validation of a robust, accurate, and precise HPLC method for the simultaneous estimation of pioglitazone hydrochloride and vildagliptin in pharmaceutical dosage forms using a Quality by Design (QbD) approach.

Keywords: Pioglitazone hydrochloride, Vildagliptin, Diabetes mellitus, HPLC, Method development and validation, QbD.