Simplified high-performance liquid chromatographic method for 5-amino-salicylic acid in plasma and urine

Fischer, Christine; Maier, Karlernst; Klotz, Ulrich

doi:10.1016/s0378-4347(00)80303-5

Cited by 46 publications

(13 citation statements)

References 12 publications

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“…Blood and urine samples from both studies were analysed for their 5‐ASA and Ac‐5‐ASA contents at AAI Industries GmbH (Neu‐Ulm, Germany) using a validated high‐performance liquid chromatography method 15 ,. 16 …”

Section: Sample Analysismentioning

confidence: 99%

“…Sampling of venous plasma. Venous blood samples (10 mL) were taken from an arm vein using an indwelling catheter with a switch valve at the following times: 0 (pre-dose), 2, 3, 4, 5, 6,7,8,9,10,11,12,13,14,15,16 and 24 h. Blood samples were immediately centrifuged at about 2500 · g for 5 min, the cells were discarded and plasma was obtained. Each plasma sample was equally divided into two tubes and frozen at ) 80°C until analysis.…”

Section: Study Medicationmentioning

confidence: 99%

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Gastrointestinal transit and 5‐ASA release from a new mesalazine extended‐release formulation

Brunner

Assandri

Kletter

et al. 2003

Aliment Pharmacol Ther

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SUMMARYBackground: Mesalazine (5-aminosalicylic acid, 5-ASA)-containing formulations represent a cornerstone in the treatment of inflammatory bowel diseases. Recently, a new formulation has been developed to provide selective and more homogeneous release of 5-ASA compared to traditional systems. Methods: In a first study, gastrointestinal transit was followed by gamma-scintigraphy after single-dose application of tablets containing 1200 mg mesalazine to 12 healthy male volunteers. 5-ASA release was verified by the assessment of plasma pharmacokinetics. In a second, 7-day, multiple-dose study, the steady state plasma pharmacokinetics, urinary excretion and safety profile were characterized after twice-daily tablet administration to 12 healthy volunteers.

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Section: Sample Analysismentioning

confidence: 99%

Section: Study Medicationmentioning

confidence: 99%

Gastrointestinal transit and 5‐ASA release from a new mesalazine extended‐release formulation

Brunner

Assandri

Kletter

et al. 2003

Aliment Pharmacol Ther

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“…Analysis of 5-ASA and its metabolite 5- N -acetylaminosalicylic acid ( N -Ac-5-ASA) in the 24 hour urine collection was performed using a standardised high pressure liquid chromatography 7. Urine samples were subjected to deproteinisation with acetonitrile, subsequent derivatisation of 5-ASA, and liquid-liquid extraction with ethylacetate.…”

Section: Methodsmentioning

confidence: 99%

Low dose balsalazide (1.5 g twice daily) and mesalazine (0.5 g three times daily) maintained remission of ulcerative colitis but high dose balsalazide (3.0 g twice daily) was superior in preventing relapses

Kruis

2001

Gut

104

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Low dose balsalazide (1.5 g twice daily) and mesalazine (0.5 g three times daily) maintained remission of ulcerative colitis but high dose balsalazide (3.0 g twice daily) was superior in preventing relapses Results-Balsalazide 3.0 g twice daily resulted in a significantly higher clinical remission rate (77.5%) than balsalazide 1.5 g twice daily (43.8%) and mesalazine 0.5 g three times daily (56.8%) (p=0.006). The respective times to relapse were 161 days, 131 days (p=0.003), and 144 days (NS). Accordingly, pairwise contrasts of the final endoscopic score demonstrated a significant diVerence (p=0.005) between the two balsalazide treatment groups while diVerences between either of these two groups and mesalazine were not statistically significant. Patients treated with balsalazide excreted less 5-ASA and N-Ac-5-ASA than patients receiving mesalazine but these diVerences were not statistically significant. Discontinuation of the trial because of adverse eVects occurred in nine patients: three in the balsalazide 1.5 g twice daily group, two in the balsalazide 3.0 g twice daily group, and four in the mesalazine 0.5 g three times daily group. No clinically important new drug safety related findings were identified in this study. Conclusions-High dose balsalazide (3.0 g twice daily) was superior in maintaining remission in patients with ulcerative colitis compared with a low dose (1.5 g twice daily) or a standard dose of mesalazine (0.5 g three times daily). All three treatments were safe and well tolerated. (Gut 2001;49:783-789)

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“…The synthesis and analysis of d3-ac-5-AS (including do-ac-5-AS) in plasma and urine by h.p.l.c. and GCIMS have been described in detail elsewhere (Fischer et al, 1981(Fischer et al, , 1984. The disposition and excretion of d3-ac-5-AS was studied in two healthy male volunteers with normal kidney and liver function following a single rectal dose of 500 mg in the form of two suppositories.…”

Section: Introduction Methodsmentioning

confidence: 99%

Is N‐acetylation of 5‐aminosalicylic acid reversible in man?

Meese¹,

Fischer²,

Klotz³

1984

Brit J Clinical Pharma

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In two healthy male subjects the disposition of deuterated N‐(2H3) acetyl‐5‐aminosalicylic acid (d3‐ac‐5‐AS) was investigated after a single rectal dose of 500 mg d3‐ac‐5‐AS. Urine and plasma were analysed by h.p.l.c. and gas chromatography mass‐spectrometry. Peak concentrations of around 0.5 microgram/ml occurred within 6 h and plasma concentrations declined thereafter with a half‐life (t1/2) of about 6 h which was confirmed by urinary excretion data. Renal clearance of d3‐ac‐5‐AS ranged between 200 and 300 ml/min and only 4.4‐ 11.2% of the dose could be recovered in the 48 h urine. Since no undeuterated ac‐5‐AS could be detected in any of the plasma and urine samples an irreversible acetylation of 5‐AS is assumed in man.

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Simplified high-performance liquid chromatographic method for 5-amino-salicylic acid in plasma and urine

Cited by 46 publications

References 12 publications

Gastrointestinal transit and 5‐ASA release from a new mesalazine extended‐release formulation

Gastrointestinal transit and 5‐ASA release from a new mesalazine extended‐release formulation

Low dose balsalazide (1.5 g twice daily) and mesalazine (0.5 g three times daily) maintained remission of ulcerative colitis but high dose balsalazide (3.0 g twice daily) was superior in preventing relapses

Is N‐acetylation of 5‐aminosalicylic acid reversible in man?

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