Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ANTI-CANCER DRUG IN ITS PHARMACEUTICAL DOSAGE FORM BY HPLC WITH FORCED DEGRADATION STUDY

Abhijeet Shinde*, Pramod Patil and Dr. Sachinkumar Patil

ABSTRACT

A novel, simple and accurate high performance liquid chromatographic method has been development with quantitative analysis of Ibrutinib. Ibrutinib is a small molecule anti-cancer drug that targets B-cell malignancies. In November 2013 Ibrutinib was approved by the FDA for the treatment of mantle cell lymphoma, and later in February 2014 for the treatment of chronic lymphocytic leukemia. Method validation is carried out according to ICH guidelines and the parameters are precision, accuracy, specificity, stability, robustness, linearity, limit of detection and limit of quantification are evaluated and the values are found to be within the acceptable limit.

Keywords: ICH Guide lines, HPLC, Forced Degradation.