Development and validation of a rapid HPLC method for simultaneous determination of tramadol, and its two main metabolites in human plasma

Rouini, Mohammad-Reza; Ardakani, Yalda Hosseinzadeh; Soltani, Faezeh; Aboul‐Enein, Hassan Y.; Foroumadi, Alireza

doi:10.1016/j.jchromb.2005.10.039

Cited by 80 publications

(51 citation statements)

References 18 publications

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“…The samples were withdrawn (5 mL) at different time intervals and replaced with equivalent amounts of fresh medium. Dissolution samples, after filtration through a 0.45-mm nylon membrane filter, were analyzed using an already reported validated HPLC method at 271 nm (15,16). After analyzing the drug content in the dissolution samples, corrections were made for volume replacement and the graph of cumulative percent of drug release vs. time was plotted.…”

Section: Evaluation Of Developed Formulationmentioning

confidence: 99%

“…The optimized mobile phase composition was phosphate buffer (0.01 mol L -1 )/acetonitrile/triethanolamine (75:25:0.1) at a flow rate of 1 mL min -1 . Injected volume was 20 mL and detection was performed at 271 nm (15,16).…”

Section: Hplc Analysismentioning

confidence: 99%

“…Extraction was repeated using another 1.25 mL of ethyl acetate. The organic phase was then evaporated under a gentle stream of air and reconstituted in 250 mL of a mobile phase (15,16).…”

Section: In Vivo Studiesmentioning

confidence: 99%

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Development and biopharmaceutical evaluation of extended release formulation of tramadol hydrochloride based on osmotic technology

Kumar¹,

Singh²,

Mishra³

2009

Acta Pharmaceutica

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Oral ingestion has been the most convenient and commonly used route of drug administration because of its flexibility and dosage form design (1). In the immediate release (IR) dosage form, there is little or no control of drug release from the dosage form, which often results in constantly changing, unpredictable, and often sub-and supra-the- Extended release formulation of tramadol hydrochloride (TRH) based on osmotic technology was developed and evaluated. Target release profile was selected and different variables were optimized to achieve it. Formulation variables such as the level of swellable polymer, plasticizer and the coat thickness of semipermeable membrane (SPM) were found to markedly affect drug release. TRH release was directly proportional to the levels of plasticizer but inversely proportional to the levels of swellable polymer and coat thickness of SPM. Drug release from developed formulations was independent of pH and agitation intensity but dependent on osmotic pressure of the release media. In vivo study was also performed on six healthy human volunteers and various pharmacokinetic parameters (c max , t max , AUC 0-24 , MRT) and relative bioavailability were calculated. The in vitro and in vivo results were compared with the performance of two commercial TRH tablets. The developed formulation provided more prolonged and controlled TRH release compared to the marketed formulation. In vitro-in vivo correlation (IVIVC) was analyzed according to the Wagner-Nelson method. The optimized formulation (batch IVB) exhibited good IVIV correlation (R = 0.9750). The manufacturing procedure was found to be reproducible and formulations were stable over 6 months of accelerated stability testing.

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Section: Evaluation Of Developed Formulationmentioning

confidence: 99%

Section: Hplc Analysismentioning

confidence: 99%

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Development and biopharmaceutical evaluation of extended release formulation of tramadol hydrochloride based on osmotic technology

Kumar¹,

Singh²,

Mishra³

2009

Acta Pharmaceutica

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“…Various methods have been reported for the determination of tramadol hydrochloride in biological fluids and in pharmaceutical preparations, including HPLC [6][7][8][9][10][11], HPTLC [12], GC [13,14], capillary electrophoresis(CE) [15,16], spectrophotometry [17][18][19], voltammetry [20] and potentiometry [21]. Each of the above methods had its own merits and disadvantages, for example , some of them were accurate and selective, but involved expensive instrumentation and were time consuming, needed preconcentration before determination because of lacking high sensitive detector; some were inherent simple but have low sensitivity .…”

Section: Introductionmentioning

confidence: 99%

Flow Injection Determination of Tramadol Based on Its Sensitizing Effect on the Chemiluminescent Reaction of Permanganate-Sulfite

Yao¹,

Zhang²,

Li³

2011

AJAC

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In this paper, a novel chemiluminescence (CL) method for the determination of tramadol has been developed by combining the flow injection technique and its sensitizing effect on the weak CL reaction between sulfite and acidic KMnO 4 . A mechanism for the CL reaction has been proposed on the basis of fluorescent and CL spectra. Under the optimized conditions, the proposed method allows the measurement of tramadol hydrochloride over the range of 0.04 -4 g/mLwith a correlation coefficient of 0.9995 (n = 8) and a detection limit of 0.01 g/mL (3σ), and the relative standard deviation for 2.0 g/mL tramadol (n = 11) is 2.1%. The utility of this method was demonstrated by determining tramadol hydrochloride in tablets and injections.

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“…Most of them are, however, difficult and/or time-consuming, requiring a derivatisation step or a specific solvent extraction. Determination of tramadol in biological samples involves an initial sample pretreatment step for the isolation of target analytes, using liquid-liquid extraction (LLE) [24][25][26][27][28][29], prior to HPLC. However, this technique has many disadvantages as it is tedious, labor intensive, time consuming and very prone to loss of analyte.…”

Section: Introductionmentioning

confidence: 99%

Preparation and utilization of a molecularly imprinted polymer for solid phase extraction of tramadol

2010

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Abstract:In this paper, a highly selective molecularly imprinted polymer (MIP) for tramadol hydrochloride, a drug used to treat moderate to severe pain, was prepared and its use as solid-phase extraction (SPE) sorbent was demonstrated. The molecularly imprinted solid-phase extraction procedure followed by high performance liquid chromatography with ultraviolet detector (MISPE-HPLC) was developed for selective extraction and determination of tramadol in human plasma and urine. The optimal conditions for molecularly imprinted solid-phase extraction (MISPE) consisted of conditioning with 1 mL methanol and 1 mL of deionized water at neutral pH, loading of tramadol sample (50 µg L −1 ) at pH 7.5, washing using 1mL acetone and elution with 3×1 mL of 10% (v/v) acetic acid in methanol. The MIP selectivity was evaluated by checking several substances with similar molecular structures to that of tramadol. Results from the HPLC analyses showed that the calibration curve of tramadol (using MIP from human plasma and urine) is linear in the ranges of 6-100 and 3-120 µg L −1 with good precisions (1.9% and 2.9% for 5.0 µg L −1 ), respectively. The recoveries for plasma and urine samples were higher than 81%.

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Development and validation of a rapid HPLC method for simultaneous determination of tramadol, and its two main metabolites in human plasma

Cited by 80 publications

References 18 publications

Development and biopharmaceutical evaluation of extended release formulation of tramadol hydrochloride based on osmotic technology

Development and biopharmaceutical evaluation of extended release formulation of tramadol hydrochloride based on osmotic technology

Flow Injection Determination of Tramadol Based on Its Sensitizing Effect on the Chemiluminescent Reaction of Permanganate-Sulfite

Preparation and utilization of a molecularly imprinted polymer for solid phase extraction of tramadol

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