European Journal of Biomedical and Pharmaceutical Sciences

STABILITY-INDICATING SPECTROPHOTOMETRIC DETERMINATION OF NALBUPHINE HYDROCHLORIDE USING FIRST DERIVATIVE OF RATIO SPECTRA AND RATIO DIFFERENCE METHODS

Khalid Abdel-Salam Attia, Mohammed Wafaa Nassar, Ahmed El-Olemy*

ABSTRACT

Spectrophotometric stability-indicating procedures are described for determination of nalbuphine hydrochloride (NAL) in pure and dosage forms. First derivative of ratio spectra (1DD) and ratio difference methods are proposed for determination of nalbuphine in presence of its oxidative degradate. Beer’s law was obeyed in the concentration range of 1-20 μg/ml for both methods. The proposed methods can selectively analyse the drug in presence of up to 80 % of its degradate with mean recoveries of 101.26± 0.48 and 98.85±0.61 for derivative ratio and ratio difference methods respectively. These methods were validated and successfully applied for the determination of NAL in its commercial preparation and 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 differences were observed regarding accuracy and precision.

Keywords: Nalbuphine; stability-indicating; derivative ratio; ratio difference.