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Research Journal of Pharmacy and Technology
Year : 2018, Volume : 11, Issue : 10
First page : ( 4587) Last page : ( 4591)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2018.00839.9

A sensitive stability indicating RP-HPLC method for the determination of Ibrutinib-An anti-cancer drug

Bindu Gujju. Hima*, Annapurna Mukthinuthalapati Mathrusri

Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM University, Visakhapatnam-530045, India

*Corresponding Author E-mail: bindureddy.frnd@gmail.com

Online published on 20 December, 2018.

Abstract

Ibrutinib is used for the treatment of mantle cell lymphoma. Mantle cell lymphoma is a fast growing cancer which begins in the cells of immune system. A new HPLC method has been proposed for the quantification of Ibrutinib. Shimadzu Model HPLC system with Kromosil column (250mm x 4.6 mm, 5μ particle size) was used for the study. Mixture of phosphate buffer and acetonitrile (45: 55, v/v) with 1.0 mL/min flow rate are the optimized chromatographic conditions and the system was monitored at 295 nm. Ibrutinib shows linearity 3.5–2100 μg/ml with regression equationy = 15528x + 251.16 (R2 = 0.9999). The LOD and LOQ were found to be 0.6927 μg/ml and 2.1578 μg/ml respectively. Stress studies were performed and the method was validated. Assay of marketed formulations was also conducted the system suitability parameters were within the acceptable limits.

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Keywords

Ibrutinib, HPLC, Validation, Stability-indicating, ICH guidelines.

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