A Validated High-Performance Liquid Chromatographic Method for the Determination Of Paracetamol and Its Major Metabolites in Urine

Abstract

A reversed-phase high-performance liquid chromatographic (RP-HPLC) method employing W-detection (248 nm) I 5 ym Resolve C18 as stationary phase (in a 8 x 100 mm Waters Radial-Pak cartridge) and 0.1 M potassium phosphate monobasic/methanol/glacial acetic acid (95:4:1, VJVJV) as mobile phase was developed for the rapid and simultaneous determination of paracetamol and its major metabolites (its glucuronide and sulphate conjugates) in urine. The method requires only minimal sample preparation and chromatographic run time is only 6 min. For determination of paracetamol, the precision (inter-assay RSD ranged from 1.60-0.66% between 5 and 3257 Copyright 0 1995 by Marcel Dekker, Inc Downloaded by [University of Calgary] at 19:05 04 February 2015 3258GOICOECHEA, LOPEZ DE ALDA, AND VILA-JATO 100 pg mL-l) and 1imit.s of detection (2 ng mL-l) were satisfactory, as were these parameters for determination of the major metabolites. In the course of studies on paracetamol bioavailability and metabolism, over 1500 samples have been assayed using this method. Herein we report its use for monitoring of the levels of paracetamol and its major metabolites in the urine of fifteen normal healthy volunteers given a single oral dose of 500 mg.

Acetaminophen presystemic biotransformation vs bioavailability in therapeutical dosage range

“…rine samples were assayed for acetaminophen and its major metabolites (glucuronide and sulphate), following the High Performance Liquid Chromatography method described in a previous study (7). The method was developed employing UV-detection (248 nm), 5 um Resolve CI8 as stationary phase (in a 8 x 100 mm Waters Radial-Pak cartridge) and 0.1 M potassium phosphate monobasic/methanol/glacial acetic acid (95: 4: 1, v/v/v) as mobile phase, what had been degassed by sonication; the flow rate was 2.5 ml min-I.…”

Liquid chromatographic determination of ceterizine hydrochloride and paracetamol in human plasma and pharmaceutical formulations

“…CTZH is official in European Pharmacopoeia [1], while PARA is official in United States Pharmacopoeia [2]. Many HPLC methods have been reported for the determination of CTZH [3][4][5][6][7][8][9][10][11][12] and PARA [13][14][15][16][17][18][19][20][21][22][23][24][25][26] in biological fluids or in pharmaceutical formulations. But, none of these methods demonstrate the simultaneous quantification of these two drugs in combination in human plasma and pharmaceutical preparations.…”

“…Moreover, the reported methods are not satisfactory for routine quality assurance for one or the other reason. Some of these methods have low sensitivity [3,7,9,[13][14][15][16][17][18][19][21][22][23] or works out only at higher concentrations of the drugs [7,10,14,[16][17][18][19][21][22][23] or need more time for analysis [11,17]. Hence, it was felt necessary to develop a simple and sensitive HPLC method, which does not suffer from the above limitations for the determination of binary combination of CTZH and PARA in human plasma and pharmaceutical formulations.…”

Simultaneous Determination of Paracetamol and Caffeine by Flow Injection–Solid Phase Spectrometry Using C18 Silica Gel as a Sensing Support

“…Its action is similar to aspirin, and is a suitable alternative for patients who are sensitive to aspirin. 1 Numerous methods have been reported for the determination of paracetamol in pharmaceuticals based on different techniques: volumetry, 2 spectrophotometry, 3-5 spectrofluorometry, 6 high-performance liquid chromatography (HPLC) with photometric [7][8][9] and FTIR 10 detection, thin-layer chromatography, 11 Raman spectrometry, 12 near infrared reflectance spectrometry, 13 electroanalytical 14,15 and FI-FTIR 16 methods. Caffeine (7-methyltheophylline, 1,3,7-trimethylxantine), a xanthine alkaloid, is a powerful stimulant of the central nervous system.…”