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Development and Validation of Ultra Performance Liquid Chromatography Method for the Estimation of Etodolac in Bulk and Its Application to Marketed Dosage Form
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| Author:
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SUMANTA MONDAL, SABYASACHI BISWAL, PRIYANKA SENAPATI, PRASENJIT MONDAL, KAUSIK BHAR, NEHA PARVEEN
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| Abstract:
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To develop a new, validated ultra-performance liquid chromatographic method for the bulk and tablet dosage form of etodolac estimation. The chromatographic separation was achieved using DIKMA Waters BEH C18 (50 x 2.6 mm, 1.7 µm) column. A mixture phosphate buffer:ethanol 10:90 v/v. was utilized as a mobile phase with the isocratic elution mode and eluent was monitored at 226 nm using UV detector. In compliance with the International Conference on Harmonization Guidelines, the strategy has been continued and validated. Stressed degradation in acidic, alkaline, peroxide, thermal and photolytic environments has also been studied. In this method etodolac was eluted at the retention time of 0.882 minute. Calibration curve plots were found linear over the concentration ranges 5-150 µg/ml for etodolac. Limit of detection was found 0.05 µg/ml and limit of quantification was found 0.25 µg/ml with a percentage recovery 100.38%. The present method was also found stable in force degradation study. The empirical evidence of all the study results showed the suitability of etodolac estimation in the form of bulk and tablet dose without any excipients intervention.
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| Keyword:
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Etodolac, Method Development, Method Validation, ICH Guidelines, UPLC.
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.03.064
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| Download:
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