Abstract

METHOD DEVELOPMENT AND VALIDATION PROCESS OF BUPROPION (A NOVEL ANTI-DEPRESSANT DRUG) BY RP-HPLC (REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY)

Hrithik Bhardwaj*, Dr. Rakesh Goyal, Dr. Dilip Agarwal, Ashok Kumar Sharma, Mohit Khandelwal and Shaneza Aman

Abstract

Product simple and precise RP-HPLC process was developed for the estimation osbervation of novel antidepressant drug bupropion with Waters X – Bridge C-18 5μm, 4.6 X 150 mm columnusing mobile phase Acetonitrile: Ammonium bicarbonate (5mM) pH-9 adjusted with 1% ALOH (25:25, %v/v). A rapid, simple and accurate RP-HPLC method was developed for the estimation of bupropion hydrochloride, using C18 column 250 x 4.6 mm i.d, 5 μm particle size in gradient mode, with mobile phase comprising of phosphate buffer (pH 4.0) and alcoholic solvent methanol. The flow rate was 1 mL min -1 and the detection wavelength was 252 nm. The retention time for bupropion hydrochloride was found to be 11.52 min. The validation was carried out in the light of ICH guidelines with respect to parameters linearity, specificity, accuracy, the limit of detection (LOD) and limit of quantification (LOQ). The proposed method showed linearity in the concentration range of 50 to 250 ppm for the drug Bupropion. The linear regression equation of Bupropion was found to be y = 6E+06x + 91344 and correlation coefficient value was found to be 0.997 indicating a high degree of linearity for the drug. The limit of detection (LOD) of bupropion was 0.5 ppm and limit of quantification (LOQ) was 2.0 ppm. The low values of %recovery and %C.V. showed that the method is precise within the acceptance limit of 5% (according to ICH guidelines).

Keywords: Range, Bupropion, Quantification, RP-HPLC, PDA detector, ICH.