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International Journal of
Research in Pharmacy and Pharmaceutical Sciences
ARCHIVES
VOL. 11, ISSUE 2 (2026)
Rp-Hplc method development and validation for the estimation of Sevabertinib in bulk and pharmaceutical dosage form
Authors
Prasada Rao M, Narasimha Rao B V, Udaya Krishna Veni A, Chaitanya C H, Chandrika D, Narasaraju G V, Sowmya K, Harshini K
Abstract
This work developed and validated a reverse phase high performance liquid chromatography method for estimating sevabertinib in pharmaceutical formulations. In statistically planned studies, a number of method aspects were changed, such as mobile phase ratio and column type, to assess how these factors affected the chromatographic separation of sevabertinib. The separation was carried out on a Inertsil ODS C18 (150 × 4.6 mm, 5 µm) at room temperature under isocratic conditions at a flow rate of 1.0 mL/min using Acetonitrile: 0.1% OPA pH 2.3 in the ratio of 65:35 (v/v). A PDA detector operating at 252 nm for a total of 8 minutes made the detection. Calibration curves were linear between 2.5 and 15 μg/mL. The calculated LOQ of 2.952μg/mL and the observed LOD of 1.126μg/mL show how sensitive the developed technique is. The %RSD being less than 2 validated the robustness and ruggedness of the approach. The assay % for formulation analysis was 99.10. Consequently, this method was frequently used to analyse sevabertinib in bulk and pharmaceutical formulations.
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Pages:72-75
How to cite this article:
Prasada Rao M, Narasimha Rao B V, Udaya Krishna Veni A, Chaitanya C H, Chandrika D, Narasaraju G V, Sowmya K, Harshini K "Rp-Hplc method development and validation for the estimation of Sevabertinib in bulk and pharmaceutical dosage form". International Journal of Research in Pharmacy and Pharmaceutical Sciences, Vol 11, Issue 2, 2026, Pages 72-75
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