Development and validation of a rapid HPLC method for the determination of ketotifen in pharmaceuticals

Drug Development and Industrial Pharmacy
Mustafa M A Elsayed

Abstract

In 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.

References

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Mar 1, 1983·Biomedical Mass Spectrometry·C Julien-LaroseJ R Kiechel
Oct 12, 1999·Journal of Chromatography. B, Biomedical Sciences and Applications·S TzvetanovN Tyutyulkova
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Citations

May 22, 2007·Analytica Chimica Acta·Nie Fei, Lu Jiuru
Feb 19, 2015·Luminescence : the Journal of Biological and Chemical Luminescence·Ali MokhtariIraj Emami
Jun 30, 2006·International Journal of Pharmaceutics·Mustafa M A ElsayedNawal M Khalafallah
Feb 3, 2009·Chemical & Pharmaceutical Bulletin·Parandis DaneshgarMohammad Reza Ganjali
May 1, 2021·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Gamal A E MostafaHaitham AlRabiah

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