Alternative analytical methods for ibrutinib quantification in pharmaceutical formulation: A statistical comparison

Abstract Ibrutinib is a drug used for the treatment of marginal zone lymphoma, mantle cell lymphocytic leukemia, chronic graft, and Waldenstrom macroglobulinemia. A simple, sensitive, fast liquid chromatographic spectrophotometric method quantification ibrutinib in pharmaceutical forms bulk was developed validated. The technique using an ODS 3 C 18 (250 mm × 4.6 i.d., 5 µm) column. mobile phase mixture 0.1% trifluoroacetic acid water acetonitrile (50/50, v/v) at flow rate 1.0 mL·min −1 . Eluent detection carried out wavelength 260 nm ultraviolet detector. retention time found to be 5.27. On other hand, determined by measuring absorbance solutions nm. techniques were validated accordance with protocols outlined International conference on harmonisation technical requirements registration pharmaceuticals human (ICH) guidelines Q2(R1). Correlation coefficients both methods greater than 0.999 concentration range 5–30 mg·mL relative standard deviation values low intraday interday precision tests. accuracy ranged 99.74–100.23% 99.32–100.76% method. limits quantitation 0.90 2.80 µg·mL 1.10 3.20 analytical can safely quality control tests determination amount products.