Volume : 11, Issue : 04, April – 2024
Title:
A NOVEL ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF REVERSE PHASE-HPLC FOR THE ESTIMATION OF DACOMITINIB IN BULK AND MARKETED PHARMACEUTICAL DOSAGE FORMS
Authors :
Dr. Madireddy Mamata
Abstract :
A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Dacomitinib, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Xterra C18 (4.6 x 150mm, 5µm) column using a mixture of Methanol and DMF (45:55% v/v) as the mobile phase at a flow rate of 0.8ml/min, the detection was carried out at 260nm. The retention time of the Dacomitinib was 2.379 ±0.02min respectively. The method produce linear responses in the concentration range of 24-120mg/ml of Dacomitinib. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations. The method was validated for accuracy, precision, linearity, robustness, ruggedness and LOD & LOQ of standard solution. The developed RP-HPLC method was found to be accurate, precise, linear, and robust and was successful applied to a pharmaceutical tablet formulation for qualitative estimation of Dacomitinib in Bulk form and Marketed Pharmaceutical Dosage forms.
Key Words: Dacomitinib, RP-HPLC, Method Development, Validation, Accuracy.
Cite This Article:
Please cite this article in press Madireddy Mamata et al., A Novel Analytical Method Development And Validation Of Reverse Phase-HPLC For The Estimation Of Dacomitinib In Bulk And Marketed Pharmaceutical Dosage Forms., Indo Am. J. P. Sci, 2024; 11 (04).
Number of Downloads : 10
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