STABILITY INDICATING ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR.pptx

STABILITY INDICATING ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR.

1. STABILITY INDICATING ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS DETERMINATION OF EMPAGLIFLOZIN AND SITAGLIPTIN PHOSPHATE MONOHYDRATE IN BULK AND SYNTHETIC MIXTURE Presented by: Yadav Raginiben Haridwarbhai III-Sem. M. Pharm Enrollment No.: 232680824015

2. INTRODUCTION OF DISEASE Diabetes mellitus (DM) is commonest endocrine disorder that affects more than 100 million people worldwide. It is caused by deficiency or ineffective production of insulin by pancreas which results in increase or decrease in concentrations of glucose in the blood. It is found to damage many of body systems particularly blood vessels, eyes, kidney, heart and nerves. (1) The high blood sugar produces the classical symptoms of polyuria (frequent urination), polydipsia (increased thirst) and polyphagia (increased hunger).The presence of DM shows increased risk of many complications such as cardiovascular diseases, peripheral vascular diseases, stroke, neuropathy, renal failure, retinopathy, blindness, amputations etc. (2)

3. Types of Diabetes Mellitus Type 1 DM or insulin dependent diabetes mellitus Type I diabetes is an autoimmune disease characterized by a local inflammatory reaction in and around islets that is followed by selective destruction of insulin secreting cells. (3) Insulin replacement therapy is the mainstay for patients with type 1 DM. (4) Type 2 DM or non-insulin dependent diabetes mellitus Type II diabetes is characterized by peripheral insulin resistance and impaired insulin secretion. (5) The cells in body don’t use insulin properly. The pancreas may not making enough insulin to keep blood glucose level in the normal range. Diet and lifestyle modifications are the cornerstone for management of type 2 DM (4) .

4. INTRODUCTION OF FORCE DEGRADATION STUDY Forced degradation is a process that involves degradation of drug products and drug substances at conditions more severe than accelerated conditions and thus generates degradation products that can be studied to determine the stability of the molecule. The ICH guideline states that stress testing is intended to identify the likely degradation products which further helps in determination of the intrinsic stability of the molecule and establishing degradation pathways, and to validate the stability indicating procedures used.