Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences and Computational Chemistry
ISSN: 0975-413X
Abstract
A NEW ANALYTICAL RP-HPLC METHOD FOR THE ESTIMATION OF VEMURAFENIB IN PURE FORM AND MARKETED PHARMACEUTICAL DOSAGE FORM
Author(s): Nilima Shukla, Pragati Ranjan Satpathy*, Madhu Chhanda Mishra, Bisakha Tripathy and Bhavna GhoshThe analytical method was developed and validated for estimation of Vemurafenib in bulk and marketed formulation by Reverse Phase - High performance liquid chromatography. The separation was carried out on Symmetry C18 (4.6mm × 150mm) 5μm column. The mobile phase consists methanol and water were consists of 45:55% v/v) at flow rate 1.0 ml/min at 260nm. The column temperature was adjusted at 40°C with injection volume 10μl. The retention time of Vemurafenib was found to be 2.379 min. The linearity of the calibration curve was linear over the concentration range 24-120 μg/ml. The developed method was validated according to the International Council for Harmonization (ICH) Guidelines. The method was validated for specificity, linearity, accuracy, precision, LOD, LOQ and robustness. The developed method was easy, rapid, linear, precise, accurate and consistent. So, the method can be successfully applied for the routine analysis of Vemurafenib in bulk and marketed pharmaceutical formulation.
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Citations : 15261
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