Development and Validation of a Rapid HPLC Method for the Determination of Ketotifen in Pharmaceuticals

ABSTRACTIn the present study, a simple, sensitive, rapid, and stability-indicating high performance liquid chromatographic (HPLC) method with ultraviolet detection for the analysis of ketotifen was developed and validated. The method was applied to the determination of ketotifen in pharmaceutical fo...

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Bibliographic Details
Published in:Drug development and industrial pharmacy 2006-01, Vol.32 (4), p.457-461
Main Author: Elsayed, Mustafa M. A.
Format: Article
Language:English
Subjects:
Anti-Allergic Agents - analysis
Assay
Biological and medical sciences
Chromatography, High Pressure Liquid - methods
General pharmacology
High performance liquid chromatography (HPLC)
Ketotifen
Ketotifen - analysis
Medical sciences
Pharmaceutical Preparations - chemistry
Pharmaceutical Preparations - standards
Pharmaceutical technology. Pharmaceutical industry
Pharmaceuticals
Pharmacology. Drug treatments
Reproducibility of Results
Sensitivity and Specificity
Solutions
Tablets
Validation
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Summary:ABSTRACTIn the present study, a simple, sensitive, rapid, and stability-indicating high performance liquid chromatographic (HPLC) method with ultraviolet detection for the analysis of ketotifen was developed and validated. The method was applied to the determination of ketotifen in pharmaceutical formulations (tablets and syrups). The HPLC method utilized isocratic elution technique with a reversed phase C8 column, detection at 297 nm and a mixture of methanol, triethylamine phosphate buffer (pH 2.8; 0.04 M), and tetrahydrofuran (43: 55: 2, v/v/v) as mobile phase at a flow rate of 1.2 mL/min. Total analysis time was about 7 min with typical retention time of ketotifen of about 5 min. The method was validated for selectivity, linearity, accuracy, and precision following International Conference of Harmonization, 1996 (ICH) recommendations. Due to its simplicity and accuracy, the method can be used for routine quality control analysis.
ISSN:0363-9045
1520-5762
DOI:10.1080/03639040500529135