Volume : 11, Issue : 10, October – 2024
Title:
VALIDATED RP-HPLC METHOD FOR DETERMINATION OF DACOMITINIB IN PURE FORM AND TABLET DOSAGE FORM BY USING RP-HPLC
Authors :
S.Roshini*, K.Usha, Ch.Sunitha
Abstract :
A new simple, selective, rapid, precise RP- HPLC method is described for the determination of Dacomitinib in bulk and marketed pharmaceutical dosage form. Chromatography was carried on a Symmetry C18 (4.6×150mm) 5µm column using a mixture of Methanol: Phosphate Buffer (pH-4.6) (25:75) V/V as the mobile phase at a flow rate of 1.0mL/min with detection at 260 nm. The retention time of the drug was 2.379min. The detector response was linear in the concentration of 10-50mcg/mL the limit of detection and limit of quantification was 2.13 and 6.31mcg/mL respectively. The % recovery was observed in the range of 98-102%. Relative standard deviation for the precision study was found <2%.The percentage assay of Dacomitinibwas 99.86%. The proposed method was validated by determining its sensitivity, accuracy and precision. The proposed method is simple, fast, accurate and precise and hence can be applied for routine quality control of Dacomitinib in bulk and marketed pharmaceutical dosage form.
Keywords: Dacomitinib, RP-HPLC, Method Development, Validation, ICH Guidelines.
Cite This Article:
Please cite this article in press S.Roshini et al Validated RP-HPLC Method For Determination Of Dacomitinib In Pure Form And Tablet Dosage Form By Using RP-HPLC..,Indo Am. J. P. Sci, 2024; 11 (10).
Number of Downloads : 10
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