The goal of this work was to use UPLC to establish a new method for quantifying Lenvatinib mesylate in bulk drug and pharmaceutical dose form, as well as to validate the method and conduct stress degradation experiments on the drug.
UPLC HSS C18 (100 mm x 2.1mm, 1.8m) column, mixture of 0.1 percent OPA and Acetonitrile (50:50) mobile phase run on an isocratic mode at a flow rate of 0.3ml/min, 240nm detection wavelength, and column oven temperature maintained at 30oC were the optimised chromatographic conditions for drug elution.
Lenvatinib's retention time was found to be 1.24 minutes. In compliance with ICH requirements, the suggested method was validated for several validation parameters. In the concentration range of 2.5g/ml – 15g/ml, the technique followed Beer's law with a correlation coefficient of 0.9996. The percent RSD and percent recovery, respectively, were found to be 0.4 and 99.66 percent – 100.30 percent. It was discovered that the procedure was accurate, precise, particular, linear, rugged, and robust. The medication was subjected to a variety of stress conditions, including acidic, basic, peroxide, neutral, photolytic, and thermal. The net degradation was found to be within acceptable bounds.
Conclusion: The devised approach for estimating Lenvatinib in pharmaceutical dosage form can be used for routine analysis.
Author(s) Details:
Jahnavi Bandla,
Department of Pharmaceutical Analysis and QA, Faculty of Pharmacy, Vishnu
Institute of Pharmaceutical Education and Research, Narsapur, Medak-502313,
Telangana, India.
S. Ganapaty,
Department of Pharmacognosy and Phytochemistry, GITAM Institute of Pharmacy
GITAM University, Rushikonda, Visakhapatnam-530045, Andhra Pradesh, India.
Please see the link here: https://stm.bookpi.org/CAPRD-V9/article/view/5963#
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