Developed and Validated for the estimation of Bupropion and Dextromethorphan in a fixed dose combination of tablet

INTRODUCTION: The aim of this study was to develop a simple, accurate, precise method for the estimation of bupropion and dextromethorphan in a fixed dose combination of tablet and robust high performance liquid chromatography (HPLC) for assay analysis for such fixed combination.

METHODS: Chromatographic analysis was performed and separations were achieved on a Denali C18 150 × 4.6 mm, 5 micron using mobile phase composition of orthophosphoric acid and acetonitrile in the ratio of 600: 400 (v/v), the flow rate of 1.0 mL/min, injection volume is 10 µL and run time 6 minutes in isocratic elution. UV detection was carried out at a wavelength of 221 nm. The temperature was maintained at 30°C.
RESULTS: A simple, accurate, precise method has been developed for the estimation of bupropion and dextromethorphan in a fixed dose combination of tablet. The optimized method included the following parameters: Column temperature of 30°C, 40% acetonitrile as the mobile phase and flow rate of 1.0 mL/min. Retention times were 2.25 min and 3.12 min for bupropion and dextromethorphan, respectively. The method was found to be linear in the range of 17.5-105 µg/mL (for R2 <0.999) and 7.5-45 µg/mL for (R2 >0.999) for bupropion and dextromethorphan, respectively. Both APIs were dissolved more than 90% within 5 min.
DISCUSSION AND CONCLUSION: A simple, reliable, economic elution RP-HPLC method for the estimation of bupropion and dextromethorphan in a fixed combination tablets dosage form. The forced degradation studies were conducted by using several degradation conditions like acidic, alkali, oxidation, thermal, UV, and neutral conditions, the proposed method was effectively employed from the resolution of sample peaks. Finally, this method was carefully validated; as a result, it can be suggested for routine analysis testing in quality control laboratory.