RP-HPLC method for degradation study of Lornoxicam.

[摘要] The main objective of this paper is to develop simple, precise, accurate stress degradation assay method for lornoxicam. For present work ACN: Water (70:30) was used as mobile phase .It showed sharp peaks and good resolution (column-Grace smart RP 80 (250×4.5Mm) 5μm), (HPLC PU – 2080 Plus, Jasco). The retention time was found to be 2.3 min. The drug showed λmax at 382 nm. The method obeys Beers-Lamberts law in the concentration range of 5-30 μg/ml for HPLC analysis. From the degradation studies Lornoxicam showed sufficient degradation in acidic and alkaline degradation. Lornoxicam was found to be less susceptible to oxidative degradation. No degradation was observed in photolytic and thermal degradation. There was no significant difference observed in degradation pattern of bulk drug and pharmaceutical formulation. ICH guidelines were followed throughout the degradation studies and the proposed method found accurate stress degradation assay method. The proposed method is precise, accurate and stability indicating, resolving the entire degradation product from the drug. Thus the proposed method can have its application in the determination, of Lornoxicam in bulk drug, as well as in presence of its degradation products.

[学科分类] 药理学