Validated LC Method for Simultaneous Analysis of Tramadol Hydrochloride and Aceclofenac in a Commercial Tablet

Kachhadia, Pankaj K.; Doshi, Ashish; Ram, Vijay R.; Joshi, H. S.

doi:10.1365/s10337-008-0829-6

Cited by 14 publications

(8 citation statements)

References 16 publications

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“…The study showed that the degradant formed is diclofenac by comparison of its standard chromatogram in both acidic and basic stress conditions [9]. Other reports [10][11][12][13][14][15] were found on simultaneous estimation of aceclofenac along with other NSAIDs by HPLC . All the above cited literature revealed that the drug is unstable under various stress conditions tested and few other degradants were formed.…”

Section: Isolation and Structural Characterization Of Degradation Promentioning

confidence: 99%

Isolation and Structural Characterization of Degradation Products of Aceclofenac by HPLC, HRMS and 2D NMR

et al. 2019

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The stability of aceclofenac under stress conditions was assessed to identify the degradation products. So, it was subjected to stress conditions like acid, base and oxidation, according to ICH guideline Q1A (R2). One degradation product formed when the drug was subjected to acid stress. Three degradation products were formed during the basic stress condition. The drug substance was found to be stable to oxidative stress. The degradants formed during the stress were separated on a C-18 column using gradient preparative HPLC elution. The only product (DP-2) formed during the acid stress and this one is same as of one of the three degradation products (DP-1, DP-2, DP-3) were formed during base stress. 1D and 2D NMR spectra and mass spectral analysis supported the proposed structures for the products. The products DP-2 and DP-3 have been reported earlier but this is the first report of product DP-1 as a degradation product of aceclofenac.

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Section: Isolation and Structural Characterization Of Degradation Promentioning

confidence: 99%

Isolation and Structural Characterization of Degradation Products of Aceclofenac by HPLC, HRMS and 2D NMR

et al. 2019

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“…Spectrophotometric determination of tramadol in pharmaceutical dosage forms was also achieved [26]. Liquid chromatography (LC) was used to determine tramadol in combination with Aceclofenac in a commercial tablet [27]. Ultrafiltration and LC-MS/MS in combination of Odesmehtyltramadol and N-desmethyltramadol in plasma [28], by Meta-analysis [29], and by GC-MS in human urine [30].…”

Section: Tramadol -Hcl (±Cis-2-[(dimethyl Amino) Methyl]-1-(m-mentioning

confidence: 99%

Simultaneous Determination of Paracetamol and Tramadol in Pharmaceutical Tablets by Derivative UV-Vis Absorption Spectrophotometry

El-Zinati¹,

Abdel-Latif²

2015

TOACJ

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Abstract:A comparative study of the use of first derivative zero order crossing spectra for the resolution of Paracetamol and Tramadol hydrochloride in mixtures has been achieved showing the success of the first derivative method in resolving and quantifying both compounds. Using the first derivative, rather than the second derivative, results in improved signal to noise ratio. The absorption spectra of prepared mixtures were scanned in the range of 200-500 nm. The linear concentration ranges were 25-112 and 6-48 µg mL -1 for paracetamol and Tramadol hydrochloride, respectively. The method has been successfully used for prediction of concentrations of both compounds in mixtures with good selectivity, high sensitivity and extremely low relative error. Statistical comparison was performed using t-test at 95% confidence level. There was no significant statistical difference between the results obtained by the first derivative method and the accepted values for both compounds. Also, the percentage errors were very low which adds to the merits of our work in terms of both sensitivity and accuracy.

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“…Literature studies show various analytical methods reported for the estimation of AC in plasma by HPLC,[ 1 2 ] LC-MS,[ 3 ] in other matrix by HPLC,[ 4 ] stability-indicating method by spectrophotometry and densitometry,[ 5 6 ] in combination with other NSAID like tramadol, paracetamol. [ 7 8 ] A UV-visible derivative spectroscopic method has been reported for AC in combination with paracetamol and tramadol. [ 9 ]…”

Section: Introductionmentioning

confidence: 99%

RP-LC gradient elution method for simultaneous determination of thiocolchicoside, aceclofenac and related impurities in tablet formulation

2014

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Objective:The aim of the present study is to develop a simple and precise HPLC method for simultaneous determination of thiocolchicoside, aceclofenac and related impurities in a tablet formulation and validate as per ICH guidelines. The aim of study extends to perform forced degradation study to trace the degradation pathways of potential degradant impurities.Materials and Methods:The separation was achieved on a 4.6 mm × 100 mm, 3 μm C18 column at 40°C with the mobile phase containing 0.1 M ammonium acetate buffer and methanol in a gradient mode at a flow rate of 1.0 mL min−1. The UV detection was carried out at 257 nm.Results:Acelofenac, thiocolchicoside and their related compounds were well separated from each other with good resolution and symmetry factor without interference of excipients. The method for assay was linear in the range of 10-200 μg mL−1 for aceclofenac and 0.4 to 8 μg mL−1 for thiocolchicoside.Conclusion:The method was validated according to ICH guidelines and the acceptance criteria for accuracy, precision, linearity, specificity, robustness, ruggedness and system suitability were met in all cases. The method was highly specific, as two related compounds of thiocolchicoside and nine related compounds of aceclofenac were well separated from each other. Stress study ensured the specificity of the method as the unknown degradation products formed during stress studies did not interfere with the determination of thiocolchicoside and aceclofenac, thus proving the stability indicating capacity of the method.

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Validated LC Method for Simultaneous Analysis of Tramadol Hydrochloride and Aceclofenac in a Commercial Tablet

Cited by 14 publications

References 16 publications

Isolation and Structural Characterization of Degradation Products of Aceclofenac by HPLC, HRMS and 2D NMR

Isolation and Structural Characterization of Degradation Products of Aceclofenac by HPLC, HRMS and 2D NMR

Simultaneous Determination of Paracetamol and Tramadol in Pharmaceutical Tablets by Derivative UV-Vis Absorption Spectrophotometry

RP-LC gradient elution method for simultaneous determination of thiocolchicoside, aceclofenac and related impurities in tablet formulation

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