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DEVELOPMENT AND VALIDATION OF METHOD FOR THE DETERMINATION OF NILOTINIB BY RP-HPLC IN BULK AND PHARMACEUTICAL DOSAGE FORMS

Keywords: RP-HPLC , Nilotinib , Method development , Validation.

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Abstract:

A RP-HPLC method in Isocratic mode was developed for the estimation of Nilotinib in bulk and pharmaceutical dosage forms. The method was employed on C-18 column using Water and Acetonitrile in the ratio 50:50 v/v as mobile phase at a flow rate of 1mL/min.The UV detection wavelength selected was 254nm.The retention time for Nilotinib was found to be 3.874 min.The linearity for the method was observed in a concentration range of 5-250μg/mL with the correlation coefficient of 0.999.The developed method was validated as per ICH guidelines. The method was found to be simple, accurate and precise. The method has been applied for the determination of Nilotinib in pharmaceutical dosage forms.

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