Volume : 13, Issue : 11, November – 2026

Title:

METHOD DEVELOPMENT AND VALIDATION OF DABRAFENIB IN BULK FORM AND MARKETED FORMULATION BY USING RP-HPLC

Authors :

Syed Hafeez Ahmed*, Syed Mohammad Ur Rahman, Ayesha Mahveen, Sk Raheeb, Hoor Ul Ain, Jawed Ahmad

Abstract :

A new Analytical simple, rapid, precise, accurate and reproducible RP-HPLC method for estimation of Dabrafenib in bulk form and marketed Pharmaceutical dosage forms. Separation of Dabrafenib was successfully achieved on a Develosil ODS HG-5 RP C18, 5µm, 15cmx4.6mm i.d. column in an isocratic mode of separation utilizing Methanol : Phosphate buffer (0.02M, pH-3.6) in the ratio of 45:55% v/v at a flow rate of 1.0 mL/min and the detection was carried out at 255nm. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision, specificity and robustness. The response was found to be linear in the drug concentration range of 12-28mcg/mL for Dabrafenib. The correlation coefficient was found to be 0.9995 for Dabrafenib. The LOD and LOQ for Dabrafenib were found to be 5.004µg/mL and 15.164µg/mL respectively. The proposed method was found to be good percentage recovery for Dabrafenib, which indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard solution with the sample solution. Therefore, the proposed method specifically determines the analyte in the sample without interference from excipients of pharmaceutical dosage forms.
Keywords: Dabrafenib, RP-HPLC, Accuracy, Precision, Robustness, ICH Guidelines.

Cite This Article:

Please cite this article in press Syed Hafeez Ahmed et al., Method Development And Validation Of Dabrafenib In Bulk Form And Marketed Formulation By Using Rp-Hplc.,. Indo Am. J. P. Sci, 2026; 13(11)

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