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A validated HPTLC method for the quantitative determination of duloxetine hydrochloride and 1-naphthol in bulk and pharmaceutical formulation

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Abstract

Duloxetine hydrochloride is an anti-depressant drug, while 1-naphthol is one of its hepatotoxic impurities. So, there was an urgent need to do simultaneous analysis for both the drug and its toxic impurity. Therefore, a validated high-performance thin-layer chromatography (HPTLC) method was established for the simultaneous separation and quantification of duloxetine hydrochloride and 1-naphthol in their binary mixture and pharmaceutical formulation. The utilized developing system consisted of a mixture of chloroform–ethyl acetate–benzene–33% ammonia solution (6:3:1:0.1, v/v). Densitometric scanning was used to detect the separated peaks at 233 nm using an ultraviolet detector. The validation of the estimated method was performed according to the International Conference on Harmonization guidelines. The results indicated that it can be used for the quality control analysis of the proposed mixture. The developed method showed advantages over the previously published TLC methods of having higher sensitivity and allowing the determination of duloxetine hydrochloride with and in the presence of its toxic impurity 1-naphthol.

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Abbreviations

DUL:

Duloxetine hydrochloride

HPTLC:

High-performance thin-layer chromatography

ICH:

International Conference on Harmonization

LOD:

Limit of detection

LOQ:

Limit of quantification

UV:

Ultraviolet

%RSD :

Percent relative standard deviation

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Authors and Affiliations

  1. Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Alshaheed Shehata Ahmad Hegazy St, Beni-Suef, 62514, Egypt

    Nessreen S. Abdelhamid, Ibrahim A. Naguib, Basma H. Anwar & Maimana A. Magdy

  2. Department of Pharmaceutical Chemistry, College of Pharmacy, Taif University, Al-Hawiah, Taif, 21974, Saudi Arabia

    Ibrahim A. Naguib

Authors
  1. Nessreen S. Abdelhamid
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  2. Ibrahim A. Naguib
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  3. Basma H. Anwar
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  4. Maimana A. Magdy
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Correspondence to Basma H. Anwar.

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Abdelhamid, N.S., Naguib, I.A., Anwar, B.H. et al. A validated HPTLC method for the quantitative determination of duloxetine hydrochloride and 1-naphthol in bulk and pharmaceutical formulation. JPC-J Planar Chromat 33, 391–396 (2020). https://doi.org/10.1007/s00764-020-00045-w

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  • DOI: https://doi.org/10.1007/s00764-020-00045-w

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