Simple liquid chromatographic method for the analysis of 5-aminosalicyclic acid and its degradation product

Haney, Paul W.; Dash, Alekha K.

doi:10.1016/s0021-9673(96)00921-1

Cited by 15 publications

(7 citation statements)

References 12 publications

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“…Samples from the pH-gradient method and the biorelevant release tests were analysed using a validated method (Haney & Dash 1997) on a Lichrosorb RP-8, 5 , 125 Â 4 mm column (Merck, Darmstadt, Germany) using methanol-phosphate buffer pH 7.4 (20:80%) as mobile phase. The flow rate was set at 1.0 mL min À1 and detection was at 331 nm.…”

Section: Mesalazinementioning

confidence: 99%

Site-specific delivery of anti-inflammatory drugs in the gastrointestinal tract: an in-vitro release model

Klein

Stein

Dressman

2005

Journal of Pharmacy and Pharmacology

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Mesalazine and budesonide are anti-inflammatory drugs that are used to induce and maintain remission of inflammatory bowel diseases (IBD), such as Crohn's disease and ulcerative colitis. Both drug substances are intended to act locally at the inflamed sites of the gastrointestinal tract. The therapeutic objective for per oral treatment with these drugs is to achieve a high concentration of the active drug at the sites of inflammation while minimizing systemic absorption. The aim of this study was to develop a test system able to reflect the changing environment that a dosage form incorporating the anti-inflammatory agent is exposed to as it moves through the gastrointestinal tract. The USP dissolution apparatus 3 was used for all experiments. Compendial, as well as biorelevant, media were used to simulate passage through the gastrointestinal tract under various physiological conditions. Different dosage forms of mesalazine (5-aminosalicylic acid, 5-ASA) and budesonide available on the German market were tested. Although all dosage forms were indicated for the same therapeutic objectives, each of the dosage forms exhibited a characteristic release pattern under in-vitro conditions simulating a passage through the fasted-state gastrointestinal tract. Results from this test series indicate that, in the case of various dosage forms of mesalazine and budesonide used for the therapy of Crohn's disease and ulcerative colitis, release patterns as the dosage form moves through the gastrointestinal tract may vary widely. As the various phenotypes of IBD have different requirements in terms of pattern of distribution of the inflamed sites, and because other aspects of gastrointestinal physiology vary within the patient population, the test methods and approach described here should be very useful in designing therapy tailored to the needs of each individual patient.

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Section: Mesalazinementioning

confidence: 99%

Site-specific delivery of anti-inflammatory drugs in the gastrointestinal tract: an in-vitro release model

Klein

Stein

Dressman

2005

Journal of Pharmacy and Pharmacology

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“…Intra-day variability showed a mean RSD of 2.51%. Haney and Dash (1997) validated the HPLC method for 5-ASA assay and the intra and inter-day precisions obtained were 1.2-4.6% and 1.1-3.5%, respectively.…”

Section: Hplc Methodsmentioning

confidence: 88%

Validation of HPLC, DPPH and nitrosation methods for mesalamine determination in pharmaceutical dosage forms

Rafael

Jabor

Casagrande

et al. 2007

Rev. Bras. Cienc. Farm.

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“…1) (5-amino-2-hydroxybenzoic acid) is an anti-inflammatory drug used to treat and also maintain the remission of mild to moderate ulcerative colitis or Crohn's disease (17,18 Mesalazine has been shown to be a potent scavenger of reactive oxygen species that plays a significant role in the pathogenesis of inflammatory bowel disease, inhibition of natural killer cell activity, inhibition of antibody synthesis, inhibition of cyclo-oxygenase and lipoxygenase pathways and impairment of neutrophil function (19). Several analytical methods have been reported for the determination of MSZ in pharmaceutical dosage forms and biological fluids including micellar electrokinetic chromatography (20), differential pulse voltammetry (21) high pressure liquid chromatography (HPLC) (22)(23)(24)(25)(26)(27), liquid chromatography-tandem mass spectrometry (LC-MS/MS) (28) and spectrophotometric analysis (29)(30)(31)(32). However, only a few spectrofluorometric methods (33,34) have been reported for the determination of MSZ in its pharmaceutical formulations.…”

Section: Introductionmentioning

confidence: 99%

Host–guest inclusion complex of mesalazine and β‐cyclodextrin and spectrofluorometric determination of mesalazine

2014

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The supramolecular interaction of mesalazine (MSZ) and β-cyclodextrin (β-CD) has been examined by ultraviolet-visible (UV-vis) light, infra-red (IR) light and fluorescence spectroscopy. The formation of an inclusion complex has been confirmed based on the changes of the spectral properties. MSZ-β-CD host-guest complex was formed in (1:1) stoichiometry and the inclusion constant (K = 1.359 × 10(2) L mol(-1) ) was ascertained by typical double reciprocal plots. Furthermore, the thermodynamic parameters (ΔG°, ΔH° and ΔS°) of (MSZ-β-CD) were obtained. Based on the remarkable enhancement of the fluorescence intensity of MSZ produced through complex formation, a simple, accurate, rapid and highly sensitive spectrofluorometric method for the determination of MSZ in aqueous solution in the presence of β-CD was developed. The measurement of relative fluorescence intensity was carried with excitation at 330 nm and emission 493 nm. All variables affecting the reactions were studied and optimized. Beer's law was obeyed in the concentration range 0.1-0.45 µg/mL. Absorbance was found to increase linearly with increasing concentration of MSZ, which is corroborated by the calculated correlation coefficient values of 0.99989. The molar absorptivity, Sandell's sensitivity, detection and quantification limits were calculated. The validity of the described methods was assessed, and the method was successfully applied to the determination of MSZ in its pharmaceutical formulation. In addition, a solid inclusion complex was synthesized by co-precipitation method.

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Simple liquid chromatographic method for the analysis of 5-aminosalicyclic acid and its degradation product

Cited by 15 publications

References 12 publications

Site-specific delivery of anti-inflammatory drugs in the gastrointestinal tract: an in-vitro release model

Site-specific delivery of anti-inflammatory drugs in the gastrointestinal tract: an in-vitro release model

Validation of HPLC, DPPH and nitrosation methods for mesalamine determination in pharmaceutical dosage forms

Host–guest inclusion complex of mesalazine and β‐cyclodextrin and spectrofluorometric determination of mesalazine

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Simple liquid chromatographic method for the analysis of 5-aminosalicyclic acid and its degradation product

Cited by 15 publications

References 12 publications

Site-specific delivery of anti-inflammatory drugs in the gastrointestinal tract: an in-vitro release model

Site-specific delivery of anti-inflammatory drugs in the gastrointestinal tract: an in-vitro release model

Validation of HPLC, DPPH and nitrosation methods for mesalamine determination in pharmaceutical dosage forms

Host–guest inclusion complex of mesalazine and β‐cyclodextrin and spectrofluorometric determination of mesalazine

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Product

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Validation of HPLC, DPPH and nitrosation methods for mesalamine determination in pharmaceutical dosage forms