Development of a Dissolution Method Validation Technique Using UV-spectrophotometry for Bosutinib 500 mg Tablet

Abstract

Bosutinib is a tyrosine kinase inhibitor used in the treatment of chronic myelogenous leukemia. Any validated dissolution study of bosutinib by UV-spectrophotometric method is yet to be published in any literature. Thus, the current study is designed to propose a validated dissolution method of bosutinib 500mg tablet using UV-spectrophotometric method. The dissolution parameters were set according to the updated dissolution guideline set by FDA. Validation parameters such as specificity, linearity and range, accuracy, precision, robustness, and system suitability were checked according to ICH guidelines. After confirming linearity and specificity of the method, accuracy was indicated afterwards by the % relative standard deviation (%RSD) value of 0.8%. The precision of the method was confirmed by intra-day repeatability (average 96.2%, %RSD 1.6) and inter-analyst intermediate precision (analyst 1: 96.2%, analyst 2: 91.91%, %RSD 2.8) studies. Further, the method was not affected by deliberately changing parameters such as wavelength. System suitability study showed that %RSD of absorbance was less than 2.0 (0.1%) while experimenting with different replicates. In summary, the study indicated that the proposed validation method for the dissolution study of bosutinib is simple, cost-effective, and replicable in any laboratory setting.