Asian Journal of Green Chemistry
3.8(Q2)
CiteScore
27
h-index

A Greenness-Assessed Chromatographic Method for Dolutegravir: Quality by Design-Based Development and Validation

Articles in Press

Document Type : Original Research Article

Authors

Moein Sharfodin Attar
Ram Suresh Sakhare
Vijayendra Swamy S. M.

Channabasweshwar Pharmacy College, Swami Ramanand Teerth Marathwada University, Nanded, Maharashtra, India

10.48309/ajgc.2026.559256.1872
Abstract
Dolutegravir (DTG), used in HIV therapy, requires precise quantification, and its increasing focus on sustainability necessitates an eco-friendly analytical procedure. In this study, a reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated using quality by design (QbD) principles to quantify DTG in bulk and finished pharmaceutical products. A quadratic design based on the response surface methodology was applied to refine the key method parameters, such as solvent proportion, flow rate, and column temperature. The optimized conditions consisted of water: methanol (60:40 v/v) with detection at 257 nm. The method was validated according to ICH Q2 (R1) guidelines. The environmental impact of the method was evaluated using the AGREE, analytical eco-Scale, complementary green analytical procedure index (Complex GAPI), blue applicability grade index (BAGI), and Assessment of Green Profile (AGP), providing a comprehensive view of its sustainability. The method demonstrated excellent performance outcomes, including strong linearity over 12.50–75.00 µg/mL (R² = 0.9995), high precision with %RSD < 1.5 % for intra- and inter-day studies, and robust system behavior despite variations in solvent ratio, flow rate, and temperature. The greenness results further highlight the strengths of the method, with AGREE (0.69), Analytical Eco-Scale (82), and BAGI (77.5) scores, confirming its alignment with environmentally conscious analytical practices. Overall, these findings confirm that the QbD-assisted RP-HPLC method is accurate, reliable, robust, and environmentally sustainable for routine quantification of DTG. Therefore, this is a practical and eco-friendly choice for pharmaceutical quality control.

Graphical Abstract

A Greenness-Assessed Chromatographic Method for Dolutegravir: Quality by Design-Based Development and Validation

Keywords

Method development
Validation
Greenness analysis, Dolutegravir, QbD, RP-HPLC
Green chemistry

Subjects

©2026 The author(s). This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit: http://creativecommons.org/licenses/by/4.0/

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Sami Publishing Company

Asian Journal of Green Chemistry

Articles in Press, Accepted Manuscript
Available Online from 22 February 2026

  • Receive Date 18 November 2025
  • Revise Date 10 December 2025
  • Accept Date 08 February 2026

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