Investigation of the profile and kinetics of degradation of rivaroxaban using HPLC, TLC-densitometry and LC/MS/MS: Application to pre-formulation studies

Abdallah, Mohamed Abou-Elwafa; Al‐Ghobashy, Medhat A.; Lotfy, Hayam M.

doi:10.1016/j.bfopcu.2015.01.002

Cited by 19 publications

(15 citation statements)

References 16 publications

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“…1,2 It has been proposed as practically insoluble in water and freely soluble in organic solvents. 3 It is rapidly absorbed from the gut and produces maximum inhibition of factor Xa within 4 h of oral administration. 4,5 It does not exert direct effects on platelets.…”

Section: Introductionmentioning

confidence: 99%

“…5 In the literature, many "high-performance liquid chromatography (HPLC)" methods are available for the quantication of rivaroxaban in its dosage forms especially tablet dosage forms. 3,[6][7][8][9][10][11][12][13][14][15][16][17][18][19] Some HPLC methods are also available for the analysis of rivaroxaban in human or rat plasma. 6,20 Some "high-performance thin layer chromatography (HPTLC)" 3,11,21 and spectrophotometric methods 11,22,23 have also been proposed for the analysis of rivaroxaban in its tablet formulations.…”

Section: Introductionmentioning

confidence: 99%

“…3,[6][7][8][9][10][11][12][13][14][15][16][17][18][19] Some HPLC methods are also available for the analysis of rivaroxaban in human or rat plasma. 6,20 Some "high-performance thin layer chromatography (HPTLC)" 3,11,21 and spectrophotometric methods 11,22,23 have also been proposed for the analysis of rivaroxaban in its tablet formulations. A "liquid chromatography-mass spectrometry (LC-MS)" method has also been proposed for pharmacokinetic assessment of rivaroxaban in humans.…”

Section: Introductionmentioning

confidence: 99%

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Ecofriendly densitometric RP-HPTLC method for determination of rivaroxaban in nanoparticle formulations using green solvents

et al. 2020

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Ecofriendly densitometric RP-HPTLC method for determination of rivaroxaban in nanoparticle formulations using green solvents

et al. 2020

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“…Linearity was observed over a concentration range of 9-113 μg/ml with correlation coefficient of 0.999. Abdallah et al [19] developed and validated an orthogonal stability-indicating testing protocol (RP-HPLC and NP-TLCdensitometry) for the quantification of Rivaroxaban. It is an amide group-containing oral anticoagulant was subjected to stress conditions commonly required for the registration of pharmaceuticals: base and acidcatalyzed hydrolysis (0.1 M, 60°C, 3-6 h), oxidation (10% H2O2, 24 h), photodegradation (300-800 nm, 24 h) and thermal decomposition (50°C, 6 h).…”

Section: Chromatographymentioning

confidence: 99%

Quantification of Anticoagulants Dabigatran, Rivaroxaban, and Prasugrel by Chromatographic and Spectrometric Techniques – Review

Jayakumari

2019

Asian J Pharm Clin Res

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A review is presented on different analytical techniques used for quantitative analysis of selected anticoagulants dabigatran, rivaroxaban, and prasugrel. Efforts have been made to collate all the relevant references to the extent possible. The review discusses the advantages and disadvantages of the cited analytical techniques, which will help to give insights into the methods used for estimation of selected anticoagulants such as dabigatran, rivaroxaban, and prasugrel, from clinical isolates, and its dosage forms. The review highlights the basic as well as advanced techniques performed for estimating dabigatran, rivaroxaban, and prasugrel. The techniques illustrated here have been demonstrated to be useful for quantitative determination of selected anticoagulants and may find application in analyzing other related properties.

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“…However, no stability indicating spectrophotometric method has been reported. An ideal stability indicating method should estimate the drug and also be able to resolve the drug from its degradation product 13,14 .…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of Stability Indicating Spectrophotometric Methods for Determination of Sulbutiamine in Tablet Dosage Form

Lotfy

Abdallah

Al‐Ghobashy

2016

Analytical Chemistry Letters

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Five sensitive, selective and precise stability-indicating spectrophotometric methods for the determination of Sulbutiamine (SUL) in the presence of its alkali-induced degradation product (DEG) were developed and validated. Method A is differential dual wavelength (D 1 DWL) applied in the analysis of SUL in binary mixture via its first derivative spectra using the difference between two points with equal amplitudes in the alkali-induced degradation product, thus DEG acts as zero contribution. Method B is second derivative spectrophotometry (D 2 ), which allowed the determination of SUL at 300.0 nm. Method C is second derivative of the ratio spectra (DD 2 ) in which SUL was determined by measuring the peak amplitude at 301.0 nm. Method D is the ratio difference spectrophotometry (RD), where the difference between amplitudes of the absorbance ratio spectra at 237.2 and 274.0 nm were recorded and Method E; Ratio subtraction (RSM) where the zero order spectra of pure SUL were extracted from their laboratory prepared mixtures, and consequently SUL can be analyzed at its maxima. The linearity for SUL was obtained within concentrations ranging from 5.00 -50.00 μg/mL with percentage recovery of 100.58 + 0.98, 99.62 ± 1.16, 100.70 ± 1.38, 100.06 + 1.00 and 99.56 + 1.00 for the five methods, respectively. IntroductionSulbutiamine(SUL)[4-[(4-amino-2-methylpyrimidin-5-yl)methyl-formyl-amino]-3-[2-[(4-mino-2-methyl-pyrimidin-5-yl)methyl-formylamino]-5-(2-methylpropanoyloxy)pent-2-en-3-l] disulfanyl-pent-3-enyl]2-methylpropanoate ( Fig. 1) 1 . Sulbutiamine is a vitamin B1 derivative which has the ability of crossing blood brain barrier due to its lipophilic nature 2 . It is used in the treatment of cognitive disorder and memory dysfunction due to decrease in the cholinergic activity 3-5 .

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Investigation of the profile and kinetics of degradation of rivaroxaban using HPLC, TLC-densitometry and LC/MS/MS: Application to pre-formulation studies

Cited by 19 publications

References 16 publications

Ecofriendly densitometric RP-HPTLC method for determination of rivaroxaban in nanoparticle formulations using green solvents

Ecofriendly densitometric RP-HPTLC method for determination of rivaroxaban in nanoparticle formulations using green solvents

Quantification of Anticoagulants Dabigatran, Rivaroxaban, and Prasugrel by Chromatographic and Spectrometric Techniques – Review

Development and Validation of Stability Indicating Spectrophotometric Methods for Determination of Sulbutiamine in Tablet Dosage Form

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