Development and validation of a new HPLC analytical method for the determination of alprazolam in tablets

A new analytical method is developed together with its latter validation study, by means of a high resolution liquid chromatography (HPLC) of reverse phase to quantify alprazolam (8-chloro-1-methyl-6-phenyl-4H-[1,2,4] triazole [4,3,-α]-[1,4] benzodiazepine) in tablets. Determination is carried out b...

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Bibliographic Details
Published in:Journal of pharmaceutical and biomedical analysis 2004-03, Vol.34 (5), p.979-987
Main Authors: Pérez-Lozano, P, Garcı́a-Montoya, E, Orriols, A, Miñarro, M, Ticó, J.R, Suñé-Negre, J.M
Format: Article
Language:English
Subjects:
Alprazolam
Alprazolam - analysis
Analysis
Analytical, structural and metabolic biochemistry
Biological and medical sciences
Chromatography, High Pressure Liquid - methods
Fundamental and applied biological sciences. Psychology
General pharmacology
Liquid chromatography
Medical sciences
Pharmaceutical dosage forms
Pharmacology. Drug treatments
Quality control
Tablets
Technology, Pharmaceutical - instrumentation
Technology, Pharmaceutical - methods
Validation
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Summary:A new analytical method is developed together with its latter validation study, by means of a high resolution liquid chromatography (HPLC) of reverse phase to quantify alprazolam (8-chloro-1-methyl-6-phenyl-4H-[1,2,4] triazole [4,3,-α]-[1,4] benzodiazepine) in tablets. Determination is carried out by means of an ODS C18 column (200mm×4.6mm i.d., 5μm particle size); the mobile phase consisted of a mixture of 0.02M buffer solution of phosphates (pH 6.0) and acetonitrile (45:55, v/v). It is pumped through the chromatographic system at a flow rate of 0.50mlmin−1. The UV detector is operated at 254nm. The validation study is carried out fulfilling the ICH guidelines in order to prove that the new analytical method, meets the reliability characteristics, and these characteristics show the capacity of an analytical method to keep, throughout the time, the fundamental criteria for validation: selectivity, linearity, precision, accuracy and sensitivity. The method is applied during the working day for the quality control of commercial alprazolam tablets in order to quantify the drug and its degradation products and to check the content uniformity test.
ISSN:0731-7085
1873-264X
DOI:10.1016/j.jpba.2003.12.012