Validation of a method for the assay of related compounds in famotidine raw materials and formulations

Validation of a method for the assay of related compounds in famotidine raw materials and formulations

A high-performance liquid chromatographic (HPLC) method has been developed for the determination of famotidine and related compounds in drug raw materials and formulations. The minimum detectable amount of the available related compounds is less than 0.02% and the minimum quantifiable amount is less...

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Veröffentlicht in:Journal of pharmaceutical and biomedical analysis 1989, Vol.7 (12), p.1705-1709
Hauptverfasser: Beaulieu, N., Graham, S.J., Sears, R.W., Lovering, E.G.
Format: Artikel
Sprache:eng
Schlagworte:
Chromatography, High Pressure Liquid
Famotidine
Famotidine - analysis
Famotidine - blood
Famotidine - urine
H2-receptor antagonists
HPLC
Humans
related compounds
Solutions
Spectrophotometry, Infrared
Spectrophotometry, Ultraviolet
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Zusammenfassung:A high-performance liquid chromatographic (HPLC) method has been developed for the determination of famotidine and related compounds in drug raw materials and formulations. The minimum detectable amount of the available related compounds is less than 0.02% and the minimum quantifiable amount is less than 0.1%. Famotidine impurity levels were between 0.5 and 2.5% in raw materials, 0.44% in one tablet sample and about 3% in an IV solution, allowing for stabilizers.
ISSN:0731-7085
1873-264X
DOI:10.1016/0731-7085(89)80184-0