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Development and Validation of RP-HPLC Method for the estimation of Dacomitinib in Pharmaceutical formulation
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| Author:
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PRIDHVI KRISHNA G, NALANDA BABY R, KAPILESWAR S
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| Abstract:
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A new selective and sensitive reverse phase high-performance liquid chromatography (RP-HPLC) method was developed for the quantification of dacomitinib in pharmaceutical dosage form. Chromatographic separation was achieved on a Zodiac, C18 column (250×4.6 mm, 5µ) using mixture of methanol, acetonitrile, and water (35:55:10, v/v) at isocratic mode, as the mobile phase at a flow rate of 1.0 mL/min and monitored at 272 nm. The retention time was 4.277 min. The calibration curve was linear over the concentration range from 50-150 µg/ml, with the coefficient value (R2) of 0.9995 and lower limit of detection of 0.60 µg/ml and lower limit of quantification of 0.182 µg/ml. The accuracy and precision of the method were within the acceptable limit. Since run time and retention time were minimized, the system developed was simple and cost-effective, and it could be used for routine analysis in quality control.
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| Keyword:
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RP-HPLC, Dacomitinib, Method validation, Retention time, Accuracy
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| EOI:
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-
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.03.201
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| Download:
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