RESEARCH PAPER
Determination of tramadol hydrochloride and its preparations by acid-base titration in non-aqueous medium
 
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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
KEYWORDS
ABSTRACT
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 %.
 
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