Spectrofluorimetric and Spectrophotometric Stability-Indicating Methods for Determination of Some Oxicams Using 7-Chloro-4-nitrobenz-2-oxa-1,3-diazole (NBD-Cl)

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Two sensitive and selective spectrofluorimetric and spectrophotometric stability-indicating methods have been developed for the determination of some non-steroidal anti-inflammatoy oxicam derivatives namely lornoxicam (Lx), tenoxicam (Tx) and meloxicam (Mx) after their complete alkaline hydrolysis. The methods are based on derivatization of alkaline hydrolytic products with 7-chloro-4-nitrobenz-2-oxa-1,3-diazole (NBD-Cl). The products showed an absorption maximum at 460nm for the three studied drugs and fluorescence emission peak at 535nm in methanol. The color was stable for at least 48h. The optimum conditions of the reaction were investigated and it was found that the reaction proceeds quantitatively at pH8, after heating in a boiling water bath for 30min. The methods were found to be linear in the ranges of 1-10μgml^<-1> for Lx and Tx and 0.5-4.0μgml^<-1> for Mx for spectrophotometric method, while 0.05-1.0μgml^<-1> for Lx and Tx and 0.025-0.4μgml^<-1> for Mx for the spectrofluorimetric method. The validity of the methods was assessed according to USP guidelines. Statistical analysis of the results revealed high accuracy and good precision. The suggested procedures could be used for the determination of the above mentioned drugs in pure and dosage forms as well as in the presence of their degradation products.
公益社団法人日本薬学会の論文
2006-05-01