DEVELOPMENT AND VALIDATION OF NEW ANALYTICAL METHOD FOR THE DETERMINATION OF IBRUTINIB IN BULK AND TABLET DOSAGE FORM

Sneha N. U.*, Suresha D. N., Naveen Kumar G. S.

ABSTRACT

A novel, simple, accurate and precise Zero order spectroscopic method was developed and validated for the determination of Ibrutinib in bulk and tablet dosage forms and has an absorption maximum at 258 nm in Acetonitrile. The Linearity was found to be in the concentration range of 2-12 μg/ml and the correlation coefficient was found to be 0.9999 and it has showed good linearity, reproducibility, precision in this concentration range. The regression equation was found to be Y = 0.0548X+ 0.0007. The % recovery values were found to be within 100.02 -100.43 % showed that the method was accurate. The LOD and LOQ were found to be 0.0957 and 0.29 μg/ml, respectively. The % RSD values were less than 2%. The method has been validated according to ICH guidelines for linearity, accuracy, precision, robustness, ruggedness. Limit of detection and limit of quantitation. Proposed method was successfully applied for the quantitative determination of Ibrutinib in bulk and tablet dosage form.

Keywords: Ibrutinib, UV- Spectroscopy, Acetonitrile, Accuracy.