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Development and validation of a high-performance thin-layer chromatography method for the estimation of bromfenac in ophthalmic solution

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Abstract

A novel, simple, precise, specific, accurate high-performance thin-layer chromatography (HPTLC) method was developed and validated for the estimation of bromfenac in ophthalmic solution. Diclofenac sodium was used as an internal standard (IS) because of its structural resemblance with bromfenac to develop a more accurate and precise method. Silica gel 60 F254 HPTLC plates were used to separate bromfenac from the formulation with a mobile phase consisting of toluene-ethyl acetate-glacial acetic acid (65:35:0.2, V/V). Densitometric scanning was performed at 274 nm after the HPTLC plates were air-dried. Well-resolved bands and good peak shapes were obtained for both bromfenac and diclofenac sodium, with retention factor (RF) values of 0.28 and 0.44, respectively. The proposed method was validated as per International Council for Harmonisation Q2 (R1) guidelines for specificity, precision, robustness, accuracy, and recovery. The drug shows linearity in the concentration range of 60‒270 ng/band and the correlation coefficient was found to be 0.999. The mean percent recovery of bromfenac was found to be 100.7%. The limit of detection and limit of quantification values for bromfenac were found to be 7.4 ng/band and 22.5 ng/band, respectively. The method was found to be novel since no HPTLC methods have yet been reported for the estimation of bromfenac. The developed method was successfully applied for the quantitative analysis of the drug in the ophthalmic formulation.

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Acknowledgements

The authors are thankful to the management of Oriental College of Pharmacy and Central Drugs Testing Laboratory, Mumbai, for the support and guidance to carry out this research work.

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Authors and Affiliations

  1. Department of Quality Assurance, Oriental College of Pharmacy, Sanpada, Navi Mumbai, 400705, India

    Merin Thomas & Vandana Jain

  2. Central Drugs Testing Laboratory – Mumbai, Zonal FDA Bhawan, GMSD Compound, Belasis Road, Mumbai, 400008, India

    Bhushan Sonawane, Edna D’Souza, M. Vijay Kumar & Raman Mohan Singh

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  1. Merin Thomas
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  2. Vandana Jain
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  3. Bhushan Sonawane
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  4. Edna D’Souza
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  5. M. Vijay Kumar
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  6. Raman Mohan Singh
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Correspondence to Vandana Jain.

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Thomas, M., Jain, V., Sonawane, B. et al. Development and validation of a high-performance thin-layer chromatography method for the estimation of bromfenac in ophthalmic solution. JPC-J Planar Chromat 35, 627–633 (2022). https://doi.org/10.1007/s00764-022-00213-0

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  • DOI: https://doi.org/10.1007/s00764-022-00213-0

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