Forced Degradation and Structural Elucidation of Aceclofenac Degradation Products Using Different Characterization Technique

Rushikesh Mahadev Batule

International Journal of Scientific Research in Chemistry, 2026, vol. 11, issue 3, 24-31

Abstract: Aceclofenac is a widely prescribed non-steroidal anti-inflammatory drug (NSAID) used in the treatment of inflammatory and musculoskeletal disorders. The chemical stability of active pharmaceutical ingredients is essential for ensuring drug safety and therapeutic effectiveness. The present investigation focuses on the identification and characterization of degradation products generated from aceclofenac under forced degradation conditions recommended by ICH guidelines. Stress studies were carried out under acidic, alkaline, oxidative, thermal, and photolytic environments to evaluate the stability profile of the drug. Degradation products were detected using liquid chromatography coupled with mass spectrometry (LC–MS) and isolated through preparative high-performance liquid chromatography (Prep-HPLC). Structural characterization of isolated impurities was accomplished using high-resolution mass spectrometry and nuclear magnetic resonance spectroscopy (¹H NMR and ¹³C NMR). Three degradation products (DP-1, DP-2, and DP-3) were detected and structurally characterized. DP-1 was identified as a new oxidative hydrolysis product, whereas DP-2 and DP-3 correspond to known degradation products associated with diclofenac-related structures. The study provides valuable information regarding degradation pathways of aceclofenac (DP-1) and supports the development of reliable stability-indicating analytical methods for pharmaceutical quality control.

Keywords: Aceclofenac; Forced degradation; LC–MS; Preparative HPLC; NMR spectroscopy; Stability-indicating method (search for similar items in EconPapers)
Date: 2026
Note: Article URL: https://ijsrch.com/home/article/view/IJSRCH261133
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Persistent link: https://EconPapers.repec.org/RePEc:cuo:ijsrch:v11:y2026:i3:id:93

DOI: 10.32628/IJSRCH261133

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