Tramadol hydrochloride [TMH],chemically known as [1R,2R]-vel-2-[dimethlamino]-1-[3-methoxyphecy] cynonexanol[figure]is asynthetic analogue of codine and is a antrally acting analgestic agent.
- It is metabolized by the anytochrom P450 enzyme system in the liver to form eleven matabolites of which 0-desmethy tramado [M1] predomilate and has anagestic properties
- It has been used since 1977 for the relief of severe physical pain and has been the most widely sold opioid analgestic drug in the world.
- TMH is official in European pharamacopeia [EP]
- It describe nonaqueoua titration with perchloric acid as tritrant the end point being located pontentiometically ultraviolet spetrophometry.
High perfomance liguid chometrography, thin layer chomatrography –detromrtry capillary isotachophysis flow injection chemileum nescence spectrometry, voitametry ion-setective-bised potentionmetry visible spectrometry, and trtrimetry for determining TMH in pharmaceutical dosage forms.
In addition, there have been part of its assay when present in combination with other drugs. TDH and ibuprofen ware assayed simultaneously by the first –order denvative spetrophytometry and HPLC with UV-detected. The TMH along with detetroprofen and haloperidot have been determine by HPLC-deode array detection [DAD] method simultaneous analysis of TMH and acceclofenac in a commercial tablet was accomplished also by HPLC with UV-detection method. Simultaneous determination of paracetamol, TNH and dompenriodone in combine dosage form using RP-HPLC has been reported by karun akaran etal.
In recent years, there has been an increased tending towards development of stability –indication analysis, using the approach to stress testing enshrimed in international conference harmonization [ICT] guideline Q2A[R2].this approach is being extended to pharmaceutical to enable accurate and prease gualification 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 etal have elevated the stability of tramadol enantiomers using a chiral stability – indicating capillary electrophoresis method and its application to pharamaceutical analysis. Chemical stability of TMH in infection has been reported by Gupta.
Ultra performance liquid chromatography [UPEC] is a relatively new technique giving new possibility in liquid chromatography especially concerning stecrise of time and anal solvent consumption. UPLC system is designed in a special way to withstand high system back pressure special analysis colume UPLC acquity UPLC BEH C18 packed with 1.7 jum partickes are used in the system. The UPLC system allows shortening analysis time up to nine time compared to used convention of HPLC system, but separation efficiency remains the same or even improve as efficiency and speed of analysis are of great importance in many application of liquid chonmatography, especially in pharmaceutical, toxicological and chemical analysis, where cost, UPLC could play significant role in the future of liquid chromatography.
Three report are found in the literature dealing with the application of UPLC with mass spectrometric dectection for the determine nations of TMH in different matrices. A sensitive UPLC-MS\MS method for TMH in urine and whole blood in forensosn context has very recently been reported kasprzk-hordarn etal. Determine TMH in surface water by solid-phase extraction and UPLC-positive etectrospray ionization mass spectrometry.
Simultaneous screening and quantification of 29 drugs abuse including TMH in oral third has seen reported by badawi atai sohd phrase extraction and UPLC-MS/MS.
Chromatography research international.
TABLE 1: linearity and regression paremetas with pressision data
Linear range ng ml-1 0.5-300
Limits of quantification [LOG], ng ml-1 0.2
Intercept [a] 19330.0
Correlation coefficeient [r] 0.9999
Standerd deviation of b,[sb] 76.0
Standerd deviation of a [sa] 13694.5
By liquid chromatography positive etectrospray ionization tender mass spectrunetry has recently been used for the multiresidue analysis of drugs of abuse in waste water and surface water.
Though a member of liquid chromate graphing method have earlier propose for TMH no attempt has been made to apply these new type of LC [UPLC] for pharmaceutical except in body fluids oral fluids and surface and waste water despite its many fold advantages.
The aim of this work was to develop a rapid, precise, accurate and validated stability indication UPLC method for the determination of tramadol HCL in bulk and tablet. This was accomplish with a water acquity UPLC system and acquity UPLC system and acquity BEH column [C18,100mm 21MM,AND 1.7 JUM]. The stability indicating power of the method was established by comparing the chromatogram obtained under optimize condition before forced degredation with those after degredation via acidic, basic, hydrytitic, oxidative then and photolytic stress condition.
HISTORY OF TRAMADOL AND ITS STASTITICS
Tramadol [brand name ultra ] is an oral, opiod pain relieving drug that is marketed under a veriety of trade names with ultram and ultracent being the most widely prescribe and recognized.
Tramadol is most often prescribe to that moderate level of pain including dental, osteoporosis, and neuropathy in both acute and chronic setting it is also improved for treating cancer pain in period lees than three months.
Tramadol is thought to be safe due to lower risk of tolerance abuse, and dependence, but it has lower clinical value then other opiates. The drugs has only about one-tenth of the pain-reducing qualities of morphine.
Tramadol stand apart from other operates for two reasons;
- Tramadol is a fully synthetic drug, which means that it is man-made and does not occur in nature. This is in contract to morphine and codine-which are natural operates derived from the opium poppy. It also differs from drugs like hydromorphine, hydro codeine, and oxycodone which, whole also semi synthetic and made in a laboratory, still retain some natural qualities.
- Tramadol has an uncommon, anal- acting benefit. Tramadol works as an opiate in the expected way to manage the perception of pain, but be young that, it allows increase availability of two other neuro transmitter chemical in the brain called norepinephrine and Serotonin-Norepinephrine is note for its ability to improve concentration, and serotonin manges an array of function including sleep and mood.
Comepared to others drugs and medications, tramadol is relatively young. The drugs was created by a German drugs and company that specialize in treating pain in 1962. The medication was tested for 15 years in 1977 under the name tramal. The drugs was a success for the company tramadol is widely prescribe around the world for pain relief .however it was not until 1995 that the drugs become available in the US. Now, the medication is quite popular in America