%0 Journal Article
%T A Stability Indicating UPLC Method for the Determination of Tramadol Hydrochloride: Application to Pharmaceutical Analysis
%A Kanakapura B. Vinay
%A Hosakere D. Revanasiddappa
%A Cijo M. Xavier
%A Pavagada J. Ramesh
%A Madihalli S. Raghu
%J Chromatography Research International
%D 2012
%I Hindawi Publishing Corporation
%R 10.1155/2012/870951
%X The use of Ultra Performance Liquid Chromatography (UPLC), with a rapid 5-minute reversed phase isocratic separation on a 1.7？μm reversed-phase packing material to provide rapid ‘‘high throughput’’ support for tramadol hydrochloride (TMH) is demonstrated. A simple, precise and accurate stability-indicating isocratic UPLC method was developed for the determination of TMH in bulk drug and in its tablets. The method was developed using Waters Aquity BEH C18 column (100？mm 2.1？mm, 1.7？μm) with mobile phase consisting of a mixture of potassium dihydrogen phosphate buffer of pH 2.8 and an equal volume of acetonitrile (60？:？40？v/v). The eluted compound was detected at 226？nm with a UV detector. The standard curve of mean peak area versus concentration showed an excellent linearity over a concentration range 0.5–300？μg？mL？1 TMH with regression coefficient (r) value of 0.9999. The limit of detection (S/N ) was 0.08？μg？mL？1 and the limit of quantification (S/N ) was 0.2？μg？mL？1. Forced degradation of the bulk sample was conducted an accordance with the ICH guidelines. Acidic, basic, hydrolytic, oxidative, thermal and photolytic degradation were used to assess the stability indicating power of the method. TMH was found to degrade significantly in acidic, basic and oxidative stress conditions and stable in thermal, hydrolytic and photolytic conditions. 1. Introduction Tramadol hydrochloride (TMH), chemically known as (1R,2R)-rel-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol (Figure 1), is a synthetic analogue of codeine and is a centrally acting analgesic agent [1]. It is metabolized by the cytochrome P450 enzyme system in the liver to form eleven metabolites of which o-desmethyltramadol (M1) predominates 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] which describe nonaqueous titration with perchloric acid as titrant the end point being located potentiometrically. Ultraviolet spectrophotometry [5, 6], high-performance liquid chromatography [6–9], thin layer chromatography-densitometry [10], capillary isotachophoresis [11], flow injection chemiluminescence spectrometry [12], voltametry [13–15], ion-selective-based potentiometry [16–22], visible spectrophotometry [23–28], and titrimetry [26, 29] for determining TMH in pharmaceutical dosage forms. Figure 1 In addition, there have been reports of its assay when present in combination with other drugs. TDH and ibuprofen were assayed
%U http://www.hindawi.com/journals/cri/2012/870951/