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PROJECT TOPIC: CHEMISTRY OF TRAMADOL

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CHAPTER ONE

  1.  INTRODUCTION

Tramadol hydrochloride [TMH], chemically known as [1R,2R]-vel-2-[dimethlamino]-1-[3-methoxyphecy] cynonexanol[figure]is a synthetic analog of codine and is a antrally acting analgestic agent.

  1. It is metabolized by the cytochrome P450 enzyme system in the liver to form eleven metabolites of which 0-desmethyl tramadol [M1] predominate and has analgesic properties
  2. It has been used since 1977 for the  relief of severe physical pain and has been the most widely sold opioid analgesic drug in the world.
  3. TMH is official in European pharmacopeia [EP]
  4. It describe nonaqueous titration with perchloric acid as titrant the end point being located potentiometrically ultraviolet spectrophotometry.

High-performance liquid chromatography, thin-layer chromatography –detromrtry capillary isotachophoresis flow injection chemileum nescience spectrometry, voltammetry ion-selective-based potentiometry visible spectrometry, and titrimetry for determining TMH in pharmaceutical dosage forms.

In addition, there has been part of its assay when present in combination with other drugs. TDH and ibuprofen were assayed simultaneously by the first–order denvative spectrophotometry and HPLC with UV-detected. The TMH along with dexketoprofen and haloperidol have been determining by the HPLC-diode array detection [DAD] method simultaneous analysis of TMH and aceclofenac in a commercial tablet was accomplished also by HPLC with UV-detection method. Simultaneous determination of paracetamol, TNH, and domperidone in combined dosage form using RP-HPLC has been reported by Karun Lankaran et al.

 In recent years, there has been an increased tending towards the development of stability –an indication analysis, using the approach to stress testing enshrined in international  conference harmonization [ICT] guideline Q2A[R2].this approach is being extended to pharmaceutical to enable accurately and please qualification of drugs in the presence of their degradation products. Though there are many reported methods of the analysis of TMH either alone or in combination with other drugs in pharmaceutical dosage forms, the literate on the stability –indication method is scarce. Mohammed et al have elevated the stability of tramadol enantiomers using a chiral stability-indicating capillary electrophoresis  method and its application to pharmaceutical analysis. Chemical stability of TMH in infection has been reported by Gupta.


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