Determination of tramadol hydrochloride and its preparations by acid-base titration in non-aqueous medium
More details
Hide details
Department of Chemistry, Manasagangothri, University of Mysore, Mysore, India
Corresponding author
Kanakapura Basavaiah   

Department of Chemistry, Manasagangothri, University of Mysore, Mysore-570 006, India.
J Pre Clin Clin Res. 2010;4(1):19-23
Tramadol hydrochloride (TMH) is a centrally-acting synthetic analgesic with μ-opioid receptor agonist activity, and is a widely prescribed analgesic used in the treatment of moderate to severe pain and an alternative to opiates. Two simple, rapid, reliable, precise and accurate and cost-eff ective non-aqueous titrimetric procedures have been developed for the determination of TMH in bulk drug and its pharmaceutical formulations. The methods are based on the titration of the drug in glacial acetic acid in the presence of mercuric acetate with acetous perchloric acid to the visual end point, using crystal violet as indicator and to the potentiometric end point. The methods were applicable over the range of 1-20 mg TMH. The procedures were also applied for the determination of TMH in its dosage forms and the results were found to be in a good agreement with those obtained by the reference method. The precision results, expressed by intra-day and inter-day relative standard deviation values, were satisfactory (RSD < 2.0%). The accuracy was also satisfactory (RE ≤ 1.76%). Excipients used as additives in pharmaceutical formulations did not interfere in the proposed procedures as shown by the recovery study via standard addition technique with percentage recoveries in the range 98.36-107.3 % with a standard deviation of ≤ 1.34 %.
Grosa G, Grosso ED, Russo R, Allegrone G: Simultaneous, stability indicating, HPLC-DAD determination of guaifenesin and methyl and propyl-parabens in cough syrup. J Pharm Biomed Anal 2006, 41, 798-803.
Lintz W, Barth H, Osterloh G, Schmidt BE: Pharmacokinetics of tramadol and bioavailability of enteral tramadol formulations. 3rd Communication: suppositories. Drug Res 1998, 48, 889-899.
‘Tramadol, Ibuprofen’, in: British Pharmacopoeia, HM Stationary Offi ce, London 2004.
Aysel K, Yucel K: Determination of tramadol hydrochloride in ampoule dosage forms by using UV spectrophotometric and HPLC-DAD methods in methanol and water media. IL Farmaco 2005, 60, 163-169.
Kartinasari WF, Palupi T, Indrayanto G: hplc determination and validation of tramadol hydrochloride in capsules. J Liq Chromatogr Rel Tech 2005, 27, 737-744.
Zaghloul IY, Radwan MA: High performance liquid chromatographic determination of tramadol in pharmaceutical dosage forms. J Liq Chromatogr Rel Tech 1997, 20, 779-787.
Zhong YL: Determination of the content of tramadol hydrochloride sustained-release tablets. Yaowu Fenxi Zazhi 1997, 17, 279-280.
Krzek J, Starek M: Quality assessment for tramadol in pharmaceutical preparations with thin layer chromatography and densitometry. Biomed Chromatogr 2004, 18, 589-599.
Pospisilova M, Polasek M, Jokl V: Determination of tramadol in various dosage forms by capillary isotachophoresis. J Pharm Biomed Anal 1998, 18, 777-783.
Ganjali MR, Memari Z, Faridbod F, Dinarvand R, Norouzi P: Sm3+ potentiometric membrane sensor as a probe for determination of some pharmaceutics. Electroanalysis, New York 2008, 20, 2663-2670.
Wu YJ, Zhang JH, Zhao KL, Zhang ZP: Preparation and application of an ion-selective electrode by tramadol hydrochloride. Fenxi Shiyanshi 2005, 24, 49-51.
Huang CL, Xiu R, Liu ZY, Li YC, Meng CJ: Preparation and application of a doubly- coated membrane tramadol ion-selective electrode based on Ag/AgCl wir. Fenxi Kexue Xuebao 2005, 21, 48-50.
Huang CL, Xiu R, Dong QX, Chen XZ, You HQ: Preparation of a PVC membrane tramadol ion-selective electrode based on gel quinhydrone internal reference electrode. Fenxi Ceshi Xuebao 2005, 24, 35-38.
Wang M, Long YL, Li DH, Zhou WB, Zhao GZ, Zhang Z: Preparation of an ofl oxacin-poly(vinyl chloride) membrane and tramadol-selective electrodes and their application. Fenxi Huaxue Fenxi 1997, 25, 448- 451.
Hopkala H, Misztal G, Wieczorek A: Tramadol selective PVC membrane electrodes and their analytical application. Die Pharmazie 1998, 53, 869-871.
Yue JL, Yu QH, Li DH, Zhao GZ, Shi W, An LR: Preparation and application of a polyvinyl chloride-membrane tramadol-selective electrode. Fenxi Huaxue 2000, 28, 84-86.
Norouzi P, Dinarvand R, Ganjali MR, Meibodi ASE: Application of adsorptive stripping voltammetry for the nano-level detection of tramadol in biological fl uids and tablets using fast fourier transform continuous cyclic voltammetry at an Au microelectrode in a fl owing system. Anal Lett 2007, 40, 2252-2270.
Garrido EMPJ, Garrido JMPJ, Borges F, Delerue-Matos C: Development of electrochemical methods for determination of tramadol – analytical application to pharmaceutical dosage forms. J Pharm Biomed Anal 2003, 32, 975-981.
Yang YZ, Lu YB: Ultra-violet-spectrophotometric determination of tramadol hydrochloride in injection solution. Yaowu Fenxi Zazhi 1996, 16, 132-132.
Mang FW, Liu W, Yang JN: Ultra-violet spectrophotometric analysis of tramadol hydrochloride injections. Yaowu Fenxi Zazhi 1994, 14, 42-42.
Zhang JK, Li JG, Tu YF: Flow injection chemiluminescence determination of tramadol hydrochloride. Fenxi Kexue Xuebao 2009, 25, 173-176.
Abdellatef HE, El-Henawee MM, El-Sayed HM, Ayad MM: Spectrophotometric and spectrofl uorimetric methods for analysis of tramadol, acebutolol and dothiepin in pharmaceutical preparations. Spectrochim Acta Part A. In: Mol Biomol Spectro 2006, 65, 1087- 1092.
Abdellatef HE: Kinetic spectrophotometric determination of tramadol hydrochloride in pharmaceutical formulation. J Pharm Biomed Anal 2002, 29, 835-842.
Sadhana RJ Trivedi Priti D: Assay of tramadol hydrochloride by spectrophotometry. Indian Drugs 2001, 38, 100-101.
Jiri Kucharski RN, Safarik LA, Text Book of ‘Titrations In Non-Aqueous Solvents’. Elsevier, Amsterdam-London-NewYork 1965, 94.
Ashutosh Kar, Pharm. Drug Anal (2nd ed.), New Age International Publisher, New Delhi 2005, 111.
Inczedy J, Lengyel T, Ure AM, IUPAC Compendium of Analytical Nomenclature: Defi nitive Rules, Blackwell Science Inc, Boston 1998.
Journals System - logo
Scroll to top