Stability-Indicating HPLC Method for Determination of Nalbuphine Hydrochloride

A simple, sensitive, stability-indicating HPLC method was developed and validated for the quantitative determination of nalbuphine hydrochloride in presence of its degradation product.The analysis was carried out on a BDS Hypersil C18 ( 250 X 4.6 X 5μm particle size) using a mobile phase consisting of 5 mM sodium acetate buffer; pH 5.5: acetonitrile (40:60, v/v). The analysis was performed at ambient temperature with a flow rate of 1 ml/min and UV detection at 210 nm. The method showed good linearity over the concentration range of 1-15 μg/ml with a lower detection limit of 0.243 and quantification limit of 0.737 μg/ml. The proposed method can selectively analyse the drug in presence of up to 87% of its oxidative degradate with mean recovery± RSD% of 100.08±0.678.The method was validated and successfully applied for determination of nalbuphine 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 difference was observed regarding accuracy and precision.