Development and Validation of a Novel RP-HPLC Method for Quantitative Estimation of Dabrafenib in Bulk Drug and Pharmaceutical Dosage Forms

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Dr.D. Varun, Dr. Subhas Sahoo, K. Naveen kumar

The measurement of Dabrafenib in bulk and pharmaceutical dose form was achieved using a reverse phase high-performance liquid chromatographic approach that was quick, straightforward, accurate, and specific. A mobile phase consisting of Methanol: Phosphate Buffer (35:65%) v/v was used to execute the separation on a Symmetry ODS C18 (4.6x250mm, 5µm) column. We used a flow rate of 1 mL/min and a UV detection wavelength of 235 nm. Room temperature was maintained for the column. The run length was under 8 minutes at these chromatographic conditions. A duration of 2.257minutes was determined for Dabrafenib. Across the concentration range of 6-14 μg mL-1, the calibration curve remained linear. Both the quantification and detection limits were 3.6 ng mL−1 and 1.2 ng mL−1, respectively. A commercial product’s recovery percentage ranged from 98% to 102%, while the average test percentage was 99.86%. Results from the investigation of accuracy indicated a relative standard deviation of less than 2%. Dabrafenib in bulk and pharmaceutical dosage forms that are commercially available may be determined using the novel method, which is user-friendly, accurate, quick, and specific.

Dabrafenib, RP-HPLC, Validation, Technique Development, and ICH Guidelines are the main terms here.