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Analytical method development, validation and studies of degradation behavior of erlotinib hydrochloride in bulk and tablet formulation by thin-layer chromatography

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Abstract

The present work describes the quantification of erlotinib hydrochloride in bulk and in pharmaceutical formulation by thin-layer chromatography (TLC). TLC was performed with ethyl acetate‒toluene‒glacial acetic acid (7:3:0.2, V/V) as the mobile phase and aluminum-backed TLC plates precoated with a 250-μm layer of silica gel 60F254 as the stationary phase. Densitometry was performed at 246 nm and validated according to the International Council for Harmonisation (ICH) guidelines. The correlation coefficient (R2) was 0.9986. The limit of detection and limit of quantification were 5 and 15 ng/zone, respectively. The precision of the method was determined by calculating the intraday (%RSD = 0.84) and interday precision (%RSD = 0.66). The mean recovery of the precision study was between 99.6% and 101.1%. The degradation behavior was also evaluated, when the active pharmaceutical ingredient (API), erlotinib hydrochloride was found to be stable under acidic, thermal, and photolytic conditions, but significantly degraded under alkaline and oxidative stress conditions. In addition, the method has been successful when applied to the quantitative determination of marketed formulations.

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Acknowledgements

We are very grateful to the Department of Chemistry and Forensic Science, Bhakta Kavi Narsinh Mehta University for providing research facilities.

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Authors and Affiliations

  1. Department of Chemistry and Forensic Science, Bhakta Kavi Narsinh Mehta University, Junagadh, Gujarat, India

    Hardik L. Varu, Rajesh A. Jadav, Atul H. Bapodra & Mrunal A. Ambasana

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  1. Hardik L. Varu
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  2. Rajesh A. Jadav
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  3. Atul H. Bapodra
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  4. Mrunal A. Ambasana
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Correspondence to Mrunal A. Ambasana.

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Varu, H.L., Jadav, R.A., Bapodra, A.H. et al. Analytical method development, validation and studies of degradation behavior of erlotinib hydrochloride in bulk and tablet formulation by thin-layer chromatography. JPC-J Planar Chromat 36, 307–313 (2023). https://doi.org/10.1007/s00764-023-00249-w

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