ANALYTICAL METHOD DEVELOPMENT OF ESOMEPRAZOLE IN BULK AND SINGLE COMPONENT FORMULATION

Esomeprazole is a proton pump inhibitor which reduces gastric acid secretion through inhibition of H⁺/K⁺-ATPase in gastric parietal cells. By inhibiting the functioning of this enzyme, the drug prevents formation of gastric acid. Esomeprazole is combined with the antibiotics, clarithromycin and amoxicillin (or metronidazole in penicillin-hypersensitive patients) in the 7-14 day eradication triple therapy for Helicobacter pylori. Infection by H. pylori is the causative factor in the majority of peptic and duodenal ulcers. Common side effects of Esomeprazole include headache, diarrhea, nausea, gas, decreased appetite, constipation, dry mouth, and abdominal pain. More severe side effects are severe allergic reactions, chest pain, dark urine, fast heartbeat, fever, paresthesia, persistent sore throat, severe stomach pain, unusual bruising or bleeding, unusual tiredness, and yellowing of the eyes or skin. Proton pump inhibitors may be associated with a greater risk of hip fractures and Clostridium difficile– associated diarrhea. Patients are frequently administered the drugs in intensive care as a protective measure against ulcers, but this use is also associated with a 30% increase in occurrence of pneumonia. It is not official in any of the Pharmacopoeias and only listed in The Merck Index and Martindale, The Complete Drug Reference. There is no official method reported for the estimation of Esomeprazole. Literature survey has indicated that there are no analytical methods for estimation of Esomeprazole single component by UV-Visible Spectrophotometry but there are few methods which are reported like RP-HPLC method, validated Kinetic Spectrophotometric in commercial dosage forms, HPLC-UV method for the determination of Esomeprazole in human urine. Hence, the objective of the work is to develop simple, precise, accurate, sensitive, rapid and economical UV-Visible Spectrophotometric methods and a new simple HPLC method of analysis for the estimation of Esomeprazole in bulk and pharmaceutical formulations