Abstract:
A simple, accurate, and precise UV spectroscopy and RP-HPLC methods were
developed and validated for simultaneous estimation of Bupropion and
Natrexone in Combination.
UV spectrophotometric method has been developed using Water as a solvent
in First Order Derivative method determination was carried out at 262.33 nm
λmax ZCP of Naltrexone and 227.19nm λmax ZCP of Bupropion. The
calibration curves were linear 10-60 μg/ml and 1-6 μg/ml for Bupropion and
Naltrexone at their respective wavelength. Both the drugs were found in good
agreement with the label claimed in the marketed formulation. In Combination
both the drugs were estimated as 98.6% and 99.4% Bupropion and Naltrexone
respectively. The RP-HPLC method has shown adequate separation of Bupropion and
Naltrexone in Combination. The separation was achieved on a Phenomenex
luna ODS C18 (250mm X 4.6 mm i.d., 5 μm particle size) with an gradient
system of Buffer(pH 3.5) :Methanol in the ratio of (70:30% v/v). The mobile
phase at a flow rate of 1.0 ml/min, injection volume 20μl and wavelength of
detection used was 238nm. The retention time for Bupropion and Naltrexone
was obtained as 7.060±0.05min and 2.550±0.1min respectively. The linearity of
method was investigated in the range of 22.5-78.75μg/ml and 2-7μg/ml for
Bupropion and Naltrexone respectively. R2 was 0.9991 and 0.9991 for
Bupropion and Naltrexone respectively. The developed method was validated as
per ICH guideline, for its accuracy, precision, LOD & LOQ and the results were
found to be satisfactory, thus the method is rapid and simple for estimation of
Bupropion and Naltrexone.
