EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

An International Peer Reviewed Journal for Pharmaceutical, Medical & Biological Sciences

An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)

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 ISSN 2394-3211

Impact Factor: 4.897

 ICV - 79.57

Abstract

STUDIES ON ANALYSIS AND STABILITY OF SULTAMICILLIN AND ITS TABLET FORMULATION

Shivani J. Patel, Prof. Dr. Jayant B. Dave, Prof. Dr. Dhrubo Jyoti Sen* and Prof. Dr. C.N. Patel

ABSTRACT

Ampicillin is a β-lactam antibiotic that is advantageously combined with sulbactam, β-lactmase inhibitor to extend antimicrobial spectrum of Ampicillin. The combination is official in USP as injectable preparation. The combination cannot be administered as orally as sulbactam is not stable at an acidic pH. Sultamicillin is a novel compound that helps to ensure administration by oral route. Sultamicillin is mutual prodrug formed by reacting Ampicillin and Sulbactam with methylene diol to form diester with carboxylic acid group of both the drugs. Sultamicillin hydrolyses into Ampicillin and Sulbactam into body, the desired drugs. Sultamicillin is difficult to handle and not very stable in solid form. Sultamicillin Hydrochloride salt greatly enhances solubility but does not solve the problem of handling difficulty and stability in solid state. Salt with toluene sulfonic acid called sultamicillin tosilate solves the problem and this is official in European Pharmacopeia and British Pharmacopeia. Sultamicillin is marketed as 375 mg capsules world over and in India for oral use. The capsules are indicated for various systemic infections including anerobes and are also used empirically where causative organisms are not known. The combination is currently used in special indications of antimicrobial therapy. Sultamicillin is an oral form of mutual prodrug antibiotic containing ampicillin, a β-lactam antibiotic and sulbactam, a β-lactamase inhibitor. Sultamicillin is used orally as tablets and is as effective as ampicillin and sulbactam injection in the empirical therapy of variety of infections. The objective was to develop suitable UV spectrophotometric and HPLC method that can separate Sultamicillin from its hydrolysis products- ampicillin and sulbactam so that they can be used for thermal & hydrolytic stability study of the drug and its tablet dosage form.

Keywords: Ampicillin, Sulbactam, Sultamicillin, Sultamicillin tosilate, Toluene sulphonic acid, Mutual prodrug, Solubility, logP, ?max-UV, IR, Reversed phase HPLC, Student’s t-test.


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Google Scholar Indian Science Publications InfoBase Index (In Process) SOCOLAR, China Research Bible, Fuchu, Tokyo. JAPAN International Society for Research activity (ISRA) Scientific Indexing Services (SIS) Polish Scholarly Bibliography Global Impact Factor (GIF) (Under Process) Universal Impact Factor International Scientific Indexing (ISI), UAE Index Copernicus CAS (A Division of American Chemical Society) USA (Under Process) Directory of Open Access Journal (DOAJ, Sweden, in process) UDLedge Science Citation Index CiteFactor Directory Of Research Journal Indexing (DRJI) Indian citation Index (ICI) Journal Index (JI, Under Process) Directory of abstract indexing for Journals (DAIJ) Open Access Journals (Under Process) Impact Factor Services For International Journals (IFSIJ) Cosmos Impact Factor Jour Informatics (Under Process) Eurasian Scientific Journal Index (ESJI) International Innovative Journal Impact Factor (IIJIF) Science Library Index, Dubai, United Arab Emirates Pubmed Database [NLM ID: 101669306] (Under Process)