DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR QUANTITATIVE ESTIMATION OF NILOTINIB CAPSULES 200 MG DOSAGE FORM
N. Venkateswara Rao* and Dr. D. Ramachandran
ABSTRACT
A new, simple, rapid, selective, precise and accurate isocratic reverse phase high performance liquid chromatography assay method has been developed for estimation of Nilotinib in capsules dosage forms. The separation was achieved by using column YMC-Pack-ODS-AQ, (150 x 4.6 mm, 5μ) mobile phase consisted of 20 mmol/L ammonium acetate buffer and methanol in the ratio of (20:80 volume/volume). The flow rate was 1.0mL/min. Nilotinib was detected using UV detector at the wavelength of 250 nm. Column temperature 40°C and sample temperature ambient and injection volume 10μL, run time 10 minutes. The retention time of Nilotinib was noted to be 4.50 min respectively. The proposed HPLC method was linear over the range of 10.05-30.016 μg/mL, the correlation coefficient was found to be 0.999. Relative standard deviation for method precision was found to be 0.59. Recovery study results are found to be good in the range of 99.8-100.6 respectively. The method was validated as per ICH guidelines. The proposed method was found to be accurate, reproducible, and consistent.
Keywords: Liquid chromatography, Nilotinib and Validation.
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