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Estimation of Ibrutinib in Dosage Form and in Bulk Drug by UV Spectrophotometric and Colorimetry Methods
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A simple, sensitive, accurate, rapid and economical Spectrophotometric and colorimetric methods was developed for estimation of Ibrutinib in pure drug and tablet dosage form. The absorbance was measured at 248nm and 552nm using ethanol as solvent system. It obeyed Beer’s law at the concentration range of 2-14µg/ml and 1- 5µg/ml with coefficient of correlation (r2 ) of 0.998 and 0.996. Limit of detection (LOD) was found to be 1.226µg/ml and1.000µg/ml Limit of quantitation (LOQ) was found to be 5.226µg/ml and 2.760µg/ml. The proposed analytical methods were validated according to ICH guidelines, yielded good results concerning range, linearity, precision, accuracy, robustness and ruggedness
Keywords
Ibrutinib, Anti-tumor drug, Spectrophotometry, Colorimetry, Ethanol, BMR, Method Validation.
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