Linagliptin_Project_Summary_Presentation.pptx

It is a ppt about the Linaglipt project summury, in which the it mostly about analytical methods development and validation of linagliptin as an antidiabetic agent.

1. Analytical Methods Development and Validation of Linagliptin as an Antidiabetic Agent By Kundan Kirtanbhai Shreemali Guided by: Chaudhary Rajeshbhai Bhikhabhai Merchant Pharmacy College, Mehsana October 2025

2. Introduction Diabetes mellitus is a chronic metabolic disorder characterized by elevated blood glucose levels caused by insulin deficiency or resistance. It can lead to severe complications if untreated.

3. History of Diabetes Ancient Egyptian and Indian physicians first described diabetes. Modern understanding developed with insulin discovery in 1921 by Banting and Best.

4. Types of Diabetes • Type 1: Autoimmune destruction of pancreatic beta cells. • Type 2: Insulin resistance with relative insulin deficiency. • Gestational: Temporary diabetes during pregnancy.

5. Symptoms and Complications Symptoms include excessive thirst, frequent urination, fatigue, and blurred vision. Complications involve cardiovascular disease, kidney failure, and neuropathy.

6. Diagnosis Diagnosis uses blood glucose tests such as fasting plasma glucose, random glucose, HbA1c, and oral glucose tolerance tests.

7. Antidiabetic Drugs Classification Includes Insulin (for Type 1) and oral agents for Type 2. Linagliptin belongs to DPP-4 inhibitors that regulate incretin hormones.

8. Linagliptin Introduction A novel DPP-4 inhibitor used to treat Type 2 Diabetes Mellitus. It enhances incretin hormones, increasing insulin and reducing glucagon secretion.

9. Pharmacokinetics Linagliptin is rapidly absorbed, highly distributed, minimally metabolized, and mainly excreted via bile and intestines, making it safe for renal patients.

10. Mechanism of Action It inhibits the DPP-4 enzyme, prolonging incretin action. This leads to higher insulin release and lower glucagon, improving glycemic control.

11. Advantages of Linagliptin • Once-daily oral dose • Weight neutral • Low risk of hypoglycemia • Safe in renal and hepatic impairment

12. Pharmacodynamics Increases GLP-1 and GIP levels, enhancing glucose-dependent insulin secretion and reducing glucagon release for better glucose control.

13. Uses Used in Type 2 Diabetes Mellitus as monotherapy or in combination with metformin, insulin, or sulfonylureas.

14. Dosage Standard adult dose: 5 mg once daily, with or without food. No dose adjustment needed in renal or hepatic impairment.

15. Adverse Effects Common: Nasopharyngitis, cough, headache. Rare: Pancreatitis, hypersensitivity, bullous pemphigoid.

16. Analytical Methods Analytical methods identify and quantify Linagliptin using techniques like UV, HPLC, UPLC, and LC-MS/MS for drug analysis.

17. UV Spectroscopy Measures absorption of UV light for compound identification and quantification. Used for quality control of pharmaceuticals.

18. HPLC Method High-Performance Liquid Chromatography separates and quantifies Linagliptin components precisely and reliably.

19. Method Validation Ensures analytical reliability through accuracy, precision, specificity, linearity, detection limits, and robustness as per ICH Q2(R1).

20. Aim of Work To review analytical method development and validation of Linagliptin as an antidiabetic agent following ICH guidelines.

21. Conclusion Linagliptin is a safe and effective DPP-4 inhibitor with unique non-renal elimination and robust analytical validation ensuring quality assurance.