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A Rapid Stability Indicating HPLC Method for Determination of Quetiapine Fumarate in Tablets and Extemporaneous Formulations

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Pharmaceutical Chemistry Journal Aims and scope

Quetiapine fumarate is an atypical antipsychotic drug, which is clinically used for the treatment of depression and bipolar disorders. A stability indicating method is required for the quality control of pharmaceutical dosage forms. This work focused on the developments of a rapid stability indicating reversed-phase HPLC-UV method for determination of quetiapine fumarate in tablets and extemporaneous formulations. Quetiapine fumarate was simultaneously determined in the presence of three impurities: quetiapine related compound B, quetiapine related compound G, and quetiapine N-oxide within 9 min. Optimal HPLC conditions were realized using Zorbax C8 column (100 mm × 4.6 cm i.d., 3 μm particle). Gradient elution utilized mobile composition of 0.15% triethylamine (pH 6.0) and acetonitrile : methanol (80:20) mixture at a flow rate of 1.2 mL/min with detection wavelength at 252 nm. The proposed method showed good linearity (r2 > 0.998), precision (RSDs ≤ 2.2), and accuracy (%recovery 96.8 – 99.4, RSD ≤ 1.9) with acceptable limits of detection (LOD ≤ 3.0 μg/mL) and quantitation (LOQ ≤ 10 μg/mL) at RSD ≤ 2.8). The method was successfully applied to the determination of quetiapine fumarate in pharmaceutical formulations and stability testing of extemporaneous formulations.

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Acknowledgements

This research project was financially supported by the Mahidol University (Grant no. 4044, Project no. 12319). The authors would like to thank Kenyaku Co. Ltd. (Bangkok, Thailand) for providing the standard quetiapine N-oxide used in this study.

Conflicts of Interest

The authors declare that they have no conflicts of interest.

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Authors and Affiliations

  1. Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Mahidol Unviersity, 447 Sri-Ayudhaya Rd., Rajathevee, Bangkok, 10400, Thailand

    Nantana Nuchtavorn

  2. Department of Pharmacy, Faculty of Pharmacy, Mahidol Unviersity, 447 Sri-Ayudhaya Rd., Rajathevee, Bangkok, 10400, Thailand

    Jiraporn Leanpolchareanchai, Duangjai Chanton & Jiraphong Suksiriworapong

  3. Center of Excellence in Innovative Drug Delivery and Nanomedicine, Faculty of Pharmacy, Mahidol University, 447 Sri-Ayudhaya Rd., Rajathevee, Bangkok, 10400, Thailand

    Jiraporn Leanpolchareanchai & Jiraphong Suksiriworapong

  4. Pharmacy Services, Somdech Phra Debaratana Medical Center, Faculty of Medicine, Ramathibodi Hospital, 270 Rama VI Rd., Rajathevee, Bangkok, 10400, Thailand

    Patcharin Supapsophon

  5. Department of Microbiology, Faculty of Pharmacy, Mahidol Unviersity, 447 Sri-Ayudhaya Rd., Rajathevee, Bangkok, 10400, Thailand

    Sumet Chongruchiroj

  6. Pharmacy Department, Faculty of Medicine, Ramathibodi Hospital, 270 Rama VI Rd., Rajathevee, Bangkok, 10400, Thailand

    Jidapa Chatmapanrangsee

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  1. Nantana Nuchtavorn
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  2. Jiraporn Leanpolchareanchai
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  6. Jidapa Chatmapanrangsee
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  7. Jiraphong Suksiriworapong
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Correspondence to Nantana Nuchtavorn or Jiraphong Suksiriworapong.

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Nuchtavorn, N., Leanpolchareanchai, J., Chanton, D. et al. A Rapid Stability Indicating HPLC Method for Determination of Quetiapine Fumarate in Tablets and Extemporaneous Formulations. Pharm Chem J 55, 845–854 (2021). https://doi.org/10.1007/s11094-021-02505-x

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  • DOI: https://doi.org/10.1007/s11094-021-02505-x

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