Development and Validation of RP-HPLC Method for the Estimation of Nilotinib in Bulk and Pharmaceutical Dosage form

Abstract

Background: This paper describes the development of a simple, accurate, sensitive, precise and rapid method for analysis and quantification of Nilotinib by reverse phase high performance liquid chromatography (RPHPLC) was developed and validated. The main objective was to identify the robust chromatographic conditions where an adequate separation of the components with quality peaks, within acceptable run time can be achieved. Nilotinib in bulk and formulations were analyzed and quantification. Methods: Nilotinib in bulk and Pharmaceutical dosage form were analyzed on Phenomenex enable C18 column (15x4.6mm, 5μm particle size) as stationary phase. Mobile phase was composed of acetonitrile and phosphate buffer (pH 5) in the ratio of 60:40 %v/v at a flow rate of 1ml/min. The elution was analyzed using PDA detector at a detection wavelength of 260nm. The proposed method was validated by International Council for Harmonization (ICH) guidelines. Results: In this study, the chromatographic peaks of Nilotinib showed good resolution with retention time of 5.401min. Nilotinib showed an excellent linearity with 0.999 of correlation coefficient. The LOD was about 10.43 ng/ml and LOQ were about 31.63 ng/ml. Other validation parameters including precision, specificity, accuracy and robustness demonstrated good reliability in the quantification of Nilotinib. Conclusion: Thus the newly developed and validated method can be conveniently used for the quantification of Nilotinib in bulk and Pharmaceutical dosage form. Retention times were decreased and that run time was also decreased so the method developed was simple and economical that can be adopted in regular quality control test in industries.