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Development and Validation for the Estimation of Assay and Forced Degradation Impurities of Goserelin Acetate Sustained-Release Implant Using HPLC and LC–MS

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Abstract

Forced degradation studies aim to systemically characterize the degradation products of an active pharmaceutical ingredient (API) and its formulations under harsh conditions that accelerate degradation. These studies are especially valuable for sustained-release products in selecting appropriate packaging materials and storage conditions in the field of pharmaceutics. To demonstrate the degradation pathways and degradation products of the API and products, mass spectrometry is used for further characterization of the degradation products. Goserelin acetate sustained-release implant, which is prepared by hot melt extrusion using biodegradable material polylactic acid-glycolic acid copolymer as a carrier, is used for the treatment of early breast cancer in premenopausal and perimenopausal women. In this study, a simple and sensitive high-performance chromatography method was established following the ICH guidance. We conducted forced degradation experiments to determine the conditions of the product. The forced degradation studies of the goserelin acetate sustained-release implant showed the presence of a single impurity during thermal degradation, as observed in the HPLC analysis. To elucidate the structure of the impurity and characterize its degradation pathway, we performed further characterization using LC–MS.

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Data Availability

The data that support the findings of this study are available from the corresponding author upon reasonable request.

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Acknowledgements

We would like to express our sincere gratitude to Shi-Yu Guo from the Science Communication program at the University of Edinburgh for providing language editing services for this article.

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The authors have not disclosed any funding.

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Author notes

  1. Dan Huang and Yufei Tian contributed equally to this paper.

Authors and Affiliations

  1. The Center for Drug Research and Development, Guangdong Pharmaceutical University, Guangzhou, 510006, Guangdong, People’s Republic of China

    Dan Huang, Yufei Tian, Yili Zheng, Mengyu Li, Xia Xu & Wen Rui

  2. Department of Immunology, School of Life Sciences and Biopharmaceuticals Engineering, Guangdong Pharmaceutical University, Guangzhou, 510006, People’s Republic of China

    Hongyuan Chen

  3. Key Laboratory of Digital Quality Evaluation of Chinese Materia Medica of State Administration of TCM, Guangzhou, 510006, Guangdong, People’s Republic of China

    Hongyuan Chen & Wen Rui

  4. Guangdong Provincial Key Laboratory of Advanced Drug Delivery Systems, Center for Drug Research and Development, Guangdong Pharmaceutical University, Guangzhou, 510006, Guangdong, China

    Wen Rui

  5. Guangdong Cosmetics Engineering & Technology Research Center, Guangzhou, 510006, People’s Republic of China

    Hongyuan Chen

Authors
  1. Dan Huang
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  2. Yufei Tian
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Contributions

DH: Conceptualized the research idea, designed the study, collected and analyzed the data, wrote the main manuscript text, reviewed and edited the manuscript. ML: Assisted in data collection, conducted statistical analysis, contributed to writing and editing of the manuscript. YT: Conducted literature review, assisted in data collection and analysis, contributed to writing and editing of the manuscript. YZ: Conducted data analysis, contributed to writing and editing of the manuscript. XX: Assisted in data collection, conducted qualitative analysis, contributed to writing and editing of the manuscript. HC: Provided critical feedback on the study design. WR: Provided overall guidance and supervision throughout the study, contributed to writing and editing of the manuscript, secured funding for the project.

Corresponding authors

Correspondence to Hongyuan Chen or Wen Rui.

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Huang, D., Tian, Y., Zheng, Y. et al. Development and Validation for the Estimation of Assay and Forced Degradation Impurities of Goserelin Acetate Sustained-Release Implant Using HPLC and LC–MS. Chromatographia 86, 595–603 (2023). https://doi.org/10.1007/s10337-023-04272-1

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  • DOI: https://doi.org/10.1007/s10337-023-04272-1

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