A Validated Stability Indicating RP-HPLC Method for Nabumetone, Identification and Characterization of Forced Degradation Products of Nabumetone Using LC-MS/MS
SANJAY SAWANT, and VIJAYA BARGE
Asian Journal of Chemistry
The objective of the present study was to report the stability of novel non-steroidal antiinflammatory drug (NSAID), nabumetone based on the information obtained from forced degradation studies. Nabumetone was subjected to forced hydrolytic, oxidative, photolytic and thermal stress in accordance with the ICH guideline Q1A (R2). The drug showed labiality under only photo-neutral condition by forming a single degradation product. HPLC separation of the drug and the degradation product was achieved on a hypersil gold C18 column (4.6 mm × 250 mm, 5 µm) using an isocratic elution method. The method was extended to LC-MS/MS for characterization of the degradation product and the pathway of decomposition was proposed. Validation of the LC-DAD method was carried out in accordance with ICH guidelines. The method met all required criteria and was applied for analysis of commercially available tablets.
Nabumetone, Stress degradation studies, Stability indicating assay method, HPLC, LC-MS