UV SPECTROSCOPIC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF PIOGLITAZONE IN BULK AND SUSTAINED-RELEASE TABLET DOSAGE FORM

Abstract

Pioglitazone is an orally administered insulin-sensitizing thiazolidinedione agent developed for the treatment of type 2 diabetes mellitus. It works by activating the nuclear peroxisome proliferator-activated receptor gamma (PPAR-γ), which increases the transcription of proteins involved in glucose and lipid metabolism. These proteins enhance the post-receptor actions of insulin in the liver and peripheral tissues, leading to improved glycaemic control without increasing endogenous insulin secretion. In placebo-controlled clinical trials, monotherapy with pioglitazone at doses of 15–45 mg/day has been shown to reduce glycosylated haemoglobin (HbA1c) levels in patients with type 2 diabetes mellitus. Additionally, combining pioglitazone 30 mg/day with pre-existing therapy such as metformin, or adding pioglitazone 15 or 30 mg/day to treatments with sulphonylureas, insulin, or voglibose, has demonstrated significant reductions in HbA1c and fasting blood glucose levels in patients with poorly controlled diabetes. Pioglitazone has also been associated with improvements in serum lipid profiles in randomized placebo-controlled studies. The drug has generally been well tolerated in adult patients of all ages. Oedema has been reported during monotherapy, and pooled data indicate that hypoglycaemia occurs in approximately 2–15% of patients when pioglitazone is added to sulphonylurea or insulin therapy. No cases of hepatotoxicity have been reported.