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Research & Reviews: A Journal of Drug Formulation, Development and Production Original Research

Analytical Technique Optimization and ICH-Directed Verification of a Reverse Phase HPLC Approach for Quantification of Bupropion Hydrochloride

  1. Ankita Sindhe Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh
  2. Kamalesh Mistry Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh
  3. Dhananjay Mistry Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh
  4. Shivam Rongpi Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh
  5. Pratyush Kumar Brahma Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh
  6. Mitul Bhoi Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh

Abstract

This method was developed for retention time, peak resolution and baseline response using Bupropion Hydrochloride under optimized conditions as validation. The method resulted in two well separated, well defined peaks, a minor peak at 7.5 minutes 12 mV and a main peak at 11.52 minutes 150 mV. At the same time, the baseline has remained stable during the chromatographic run and the fluctuations of noise are very small (0.5 ± 0.4 mV) between 5 and 11 min (0.3 ± 0.2 mV) between 14 and 17 min (0.4 ± 0.2 mV), which indicates that the method was robust and instrumentally consistent. The chromatogram showed sharp, symmetrical peaks and consistent retention times and acceptable signal to noise ratios in the satisfactory analytical method to be relied upon. The developed method is found to be suitable for routine quantitative analysis and quality control applications in pharmaceutical laboratories, and this study provides confirmation of suitability.

Keywords

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