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

Abstract

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.

Development and Validation of HPLC Method for the Quantification of Impending Genotoxic Impurities in Dapson Drug Substances

“…The sensitivity criteria for the analytical method to be used are mostly determined by the concentration limit for a GTI [7,8]. By splitting GTIs into two groups based on their volatility, one can choose an analytical technique [2,7,8,10].…”