Development and Validation of a Method for Simultaneous Estimation of Bupropion and Dextromethorphan Using Reverse Phase High Performance Liquid Chromatography in Active Pharmaceutical Ingredient Form

Aims: New validated method for the simultaneous estimation of Bupropion and Dextromethorphan using HPLC.

Place and Duration of Study: Department of Chemistry, RVR & JC College of Engineering, Chowdavaram, Guntur, Andhra Pradesh, between July 2022 and August 2022.

Methodology: Using Inertsil ODS 250 x 4.6 mm, 5 µm column, acetonitrile and 0.1 percent formic acid (30:70 v/v) as a mobile phase, the proposed method successfully achieved effective chromatographic separation with a flow rate of 1 mL/min and a wave length of 240 nm. The Bupropion and Dextromethorphan peaks were resolved within 5 minutes of elution time, with the Bupropion peak eluting at 2.054 minutes and the Dextromethorphan peak eluting at 3.940 minutes.

Results: The proposed method displays excellent linearity in the concentration ranges of 52.5-315 µg/mL for Bupropion and 22.5-135 µg/mL for Dextromethorphan. The RSD of robustness levels has a maximum of just 2 percent.

Conclusion: The accuracy, specificity, and sensitivity of the method were all found to be in line with ICH guidelines, when the procedure was developed and tested.