Study of stability of methotrexate in acidic solution Spectrofluorimetric determination of methotrexate in pharmaceutical preparations through acid-catalyzed degradation reaction

Sabry, Suzy M.; Abdelhady, MohamedA; Elsayed, M. Abdel-Hady; Fahmy, Osama T; Maher, Hadir M.

doi:10.1016/s0731-7085(03)00239-5

Cited by 43 publications

(19 citation statements)

References 42 publications

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“…MTX decomposes similarly [14]. Hydrolysis of the amide bond is also reported in strong acidic medium, leading to 4-[N-(2,4-diamino-6-pteridinylmethyl)-N-methylamino]benzoic acid (DAMPA) and glutamic acid [15].…”

Section: Acid-base Properties Of Biological Pteridinesmentioning

confidence: 98%

Determination of dissociation constants of folic acid, methotrexate, and other photolabile pteridines by pressure-assisted capillary electrophoresis

Szakács

Noszál

2006

Electrophoresis

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Section: Acid-base Properties Of Biological Pteridinesmentioning

confidence: 98%

Determination of dissociation constants of folic acid, methotrexate, and other photolabile pteridines by pressure-assisted capillary electrophoresis

Szakács

Noszál

2006

Electrophoresis

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“…This subject was recently reviewed by Rubino [5]; a number of spectrophotometric and chromatographic methods (UV and fluorimetric detection) were proposed for the analysis of metabolites in biological samples, whereas a limited attention was given to the determination of the purity profile. Recently, a spectrofluorimetric determination was developed to perform a stability study of MTX under acidic condition, involving only one degradation product [6]. Chromatographic approaches were proposed using both ion-exchange (DEAE cellulose) and reversed-phase columns for separation of the achiral related substances [7].…”

Section: Introductionmentioning

confidence: 99%

Determination of the chiral and achiral related substances of methotrexate by cyclodextrin‐modified micellar electrokinetic chromatography

et al. 2004

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A cyclodextrin-modified micellar electrokinetic chromatographic (CD-MEKC) method for the determination of the most important potential impurities of methotrexate (MTX): 2,4-diamino-6-(hydroxymethyl)pteridine, aminopterine hydrate, 4-[N-(2-amino-4-hydroxy-6-pteridinylmethyl)-N-methylamino] benzoic acid, 4-[N-(2,4-diamino-6-pteridinylmethyl)-N-methylamino] benzoic acid, and the distomer D-MTX is presented. The MEKC separation of these compounds was optimized by applying a step-by-step approach. The addition of beta-CD to a conventional MEKC system, based on sodium dodecyl sulfate (SDS) as surfactant, showed to be essential for the enantioresolution of racemic MTX as well as for the separation of the achiral impurities. To achieve high-resolution factor between the peaks adjacent to the main component (L-MTX), as required in the analysis of related impurities, the separation conditions were stressed; in particular, the addition of methanol to the CD-MEKC system resulted in a very effective choice. Under the optimized final conditions (100 mM SDS and 45 mM beta-CD in a mixture of 50 mM borate buffer, pH 9.30-methanol (75:25 v/v)), the method was validated showing a general adequate accuracy (93-106% recovery) in the determination of L-MTX related substances at the impurity level of 0.12% w/w with a relative standard deviation (RSD)% lower than 8% (n = 4). The method was successfully applied to the analysis of pharmaceuticals (tablets and injections) which showed to contain the distomer D-MTX as major impurity and aminopterine hydrate as a further related substance in the commercial tablets.

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“…The assay of propofol in the microemulsion formulation, however, was slightly decreased during the stability test. The change in assay could be described by a following kinetic equation (Garrett and Carper, 1955;Sabry et al, 2003):…”

Section: Discussionmentioning

confidence: 99%

Formulation and evaluation of an alternative triglyceride-free propofol microemulsion

Cho

Lee

et al. 2010

Arch. Pharm. Res.

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A new triglyceride-free propofol microemulsion for intravenous injection was formulated using nonionic surfactants, poloxamers and polyethylene glycol 660 hydroxystearate. The aim of this investigation was to evaluate the formulation for storage stability, antimicrobial activity, toxicity and preclinical efficacy. The results were compared to the characteristics obtained for the most commonly used formulation of propofol (Diprivan®). The mean particle diameter of the microemulsion was less than 100 nm so that it could be readily sterilized using a 0.22 μm membrane at room temperature. The microemulsion formulation demonstrated enhanced stability compared to the marketed macroemulsion formulation. In a stress storage condition, it was physicochemically stable for at least 40 months. This new formulation showed higher antimicrobial activity, lower risk of hyperlipidemia and better tolerability than Diprivan®. In preclinical studies, the efficacy and pharmacokinetic profile of the microemulsion were similar to those of Diprivan®. Nevertheless, the administration of the microemulsion caused considerably low histamine release compared to the macroemulsion. Based on these results, the newly developed microemulsion of propofol appeared to have several advantages and, thus, could be an alternative to the fat macroemulsions of propofol.

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Study of stability of methotrexate in acidic solution Spectrofluorimetric determination of methotrexate in pharmaceutical preparations through acid-catalyzed degradation reaction

Cited by 43 publications

References 42 publications

Determination of dissociation constants of folic acid, methotrexate, and other photolabile pteridines by pressure-assisted capillary electrophoresis

Determination of dissociation constants of folic acid, methotrexate, and other photolabile pteridines by pressure-assisted capillary electrophoresis

Determination of the chiral and achiral related substances of methotrexate by cyclodextrin‐modified micellar electrokinetic chromatography

Formulation and evaluation of an alternative triglyceride-free propofol microemulsion

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