Validation of Liquid Chromatographic Method of Assay for Acetaminophen, Butalbital and Caffeine in Solid Dosage Forms

Autor:	Gregory V. Williams, Aqeel A. Fatmi
Rok vydání:	1987
Předmět:	Pharmacology Chromatography Resolution (mass spectrometry) Calibration curve Organic Chemistry Pharmaceutical Science Excipient Standard solution Dosage form Dibutylamine Acetaminophen chemistry.chemical_compound Butalbital chemistry Drug Discovery medicine medicine.drug
Zdroj:	Drug Development and Industrial Pharmacy. 13:2811-2821
ISSN:	1520-5762 0363-9045
DOI:	10.3109/03639048709022091
Popis:	The validation of a liquid chromatographic procedure for the determination of acetaminophen, butalbital and caffeine in solid dosage forms is described. The dosage content of tablets or capsules is diluted and chromatographed on a Radialpak Cyanopropylsilane Cartridge with a mobile phase of water-acetonitrile-1M dibutylamine phosphate (90+9+1, V/V) with detection at 215 nm. The calibration curve is linear with correlation coefficients of 0.999 for each component. Recoveries of spiked excipient blend averaged 99.5% for acetaminophen, 102.5% for butalbital and 101.0% for caffeine. The method met USP requirements for system suitability with proper resolution between two adjacent peaks. The relative standard deviation (RSD) of peak response of each component (obtained by chromatographing six replicates of standard solution) is less than 2.0% and the tailing factor of each component is not greater than 1.5. The method can be used for composite, content uniformity and dissolution assay of acetaminophen,...
Databáze:	OpenAIRE
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