STABILITY-INDICATING SPECTROFLUORIMETRIC DETERMINATION OF NALBUPHINE HYDROCHLORIDE IN RAW MATERIAL AND PHARMACEUTICAL PREPARATIONAbstract
A Simple, rapid, sensitive, accurate and precise spectrofluorimetric method has been developed for selective determination of nalbuphine hydrochloride (NAL) in presence of its oxidative degradate in bulk powder and in pharmaceutical preparation. The proposed method is based on measuring the native fluorescence of NAL in acetonitrile at 337 nm after excitation at 285 nm. All variables that affect fluorescence intensity such as diluting solvents and pH were studied and optimized .The fluorescence–concentration plot was rectilinear over the range of 1-12 µg/ml with a lower detection limit (LOD) of 0.175 µg/ml and lower quantitation limit (LOQ) of 0.529 µg/ml. The proposed method can selectively analyse the drug in presence of up to 75% of its oxidative degradate with mean recovery of 101.37±0.72. The method was validated and successfully applied for the determination of NAL in its commercial preparation with an average percent recovery ± RSD% of 100.14 ± 0.89. The obtained results were statistically compared with those of the reported method by applying t-test and F-test at 95% confidence level and no significant difference was observed regarding accuracy and precision.
Khalid A. Attia, Mohammed W. Nassar and Ahmed El-Olemy Allam*
Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Al-Azhar University, Cairo, Egypt
15 November, 2013
09 January, 2014
26 March, 2014