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

Year : 2025 | Volume : 12 | Issue : 02 | Page : 47 54
    By

    Ankita Sindhe,

  • Kamalesh Mistry,

  • Dhananjay Mistry,

  • Shivam Rongpi,

  • Pratyush Kumar Brahma,

  • Mitul Bhoi,

  1. Research Scholar, Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh, Rajasthan, India
  2. Assistant Professor, Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh, Rajasthan, India
  3. Lecturer, Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh, Rajasthan, India
  4. Assistant Professor, Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh, Rajasthan, India
  5. Assistant Professor, Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh, Rajasthan, India
  6. Assistant Professor, Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh, Rajasthan, India

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: Bupropion Hydrochloride, RP-HPLC, technique optimization, technique verification, ICH standards, analytical chemistry, pharmaceutical analysis

[This article belongs to Research & Reviews: A Journal of Drug Formulation, Development and Production ]

How to cite this article:
Ankita Sindhe, Kamalesh Mistry, Dhananjay Mistry, Shivam Rongpi, Pratyush Kumar Brahma, Mitul Bhoi. Analytical Technique Optimization and ICH-Directed Verification of a Reverse Phase HPLC Approach for Quantification of Bupropion Hydrochloride. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2025; 12(02):47-54.
How to cite this URL:
Ankita Sindhe, Kamalesh Mistry, Dhananjay Mistry, Shivam Rongpi, Pratyush Kumar Brahma, Mitul Bhoi. Analytical Technique Optimization and ICH-Directed Verification of a Reverse Phase HPLC Approach for Quantification of Bupropion Hydrochloride. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2025; 12(02):47-54. Available from: https://journals.stmjournals.com/rrjodfdp/article=2025/view=217372


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Regular Issue Subscription Original Research
Volume 12
Issue 02
Received 03/04/2025
Accepted 16/04/2025
Published 22/07/2025
Publication Time 110 Days
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