Development and application of an HPLC method for erlotinib protein binding studies
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Soheila Bolandnazar1, Adeleh Divsalar, Hadi Valizadeh
1Department of Biological Sciences, Kharazmi University, Tehran, Iran. ; Biotechnology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
Purpose:
The aim of the present study was to develop a simple and rapid reversed-phase high performance liquid chromatographic method with UV detection for erlotinib hydrochloride quantification, which is applicable for protein binding studies.
Methods:
Ultrafilteration method was used for protein binding study of erlotinib hydrochloride. For sample analysis a simple and rapid reversed-phase high performance liquid chromatographic method with UV detection at 332 nm was developed. The mobile phase was a mixture of methanol, acetonitril and potassium dihydrogen phosphate buffer (15:45:40 %v/v) set at flow rate of 1.3 ml/min.
Results:
The run time for erlotinib hydrochloride was approximately 6 minutes. The calibration curve was linear over the range of 320-20000 ng/ml with acceptable intra- and inter-day precision and accuracy. The intra-day and inter-day precisions were less than 10% and the accuracies of intra and inter-day assays were within the range of 97.20-104.83% and 98.8-102.2% respectively.
Conclusion:
Based on the obtained results, a simple, accurate and precise reversed-phase isocratic HPLC method with UV detection has been optimized and validated for the determination of erlotinib hydrochloride in biological samples.
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