Development and validation of a rapid HPLC method for the determination of ketotifen in pharmaceuticals.
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.
Elsayed
Mustafa M A
MM
Department of Pharmaceutics, Faculty of Pharmacy, University of Alexandria, Alexandria, Egypt. ph_mustafa@yahoo.com
D018926:Anti-Allergic Agents / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D007665:Ketotifen / Q000032:analysis*; D004364:Pharmaceutical Preparations / Q000737:chemistry* / Q000592:standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012996:Solutions; D013607:Tablets
D018926:Anti-Allergic Agents; D004364:Pharmaceutical Preparations; D012996:Solutions; D013607:Tablets; D007665:Ketotifen