The Estimation of Nilotinib in Capsule Dosage Form by RP-HPLC

A simple, precise, rapid and accurate reverse phase HPLC method was developed for the estimation of Nilotinib in capsule dosage form. A RP Inertsil ODS-3V C-18, 250x4.6 mm, 5m partical size, with mobile phase consisting of 0.02M Dipotassium hydrogen orthophosphate in water pH-2.5 with orthophosphoric acid and Acetonitrile in the ratio of 60:40 v/v was used. The flow rate was 1.0 ml/min and the effluents were monitored at 266 nm. The retention time was 8.508 min. The detector response was linear in the concentration of 80-240μg/ml. The respective linear regression equation being Y= 81268.215X+174323.3. The limit of detection and limit of quantification was 0.1μg and 0.3μg/ml respectively. The percentage assay of Nilotinib was 99.61%. The method was validated by determining its accuracy, precision and system suitability.

The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Nilotinib in bulk drug and in its pharmaceutical dosage form.