Author(s):
Moein S Attar, Divya D. Bhandare, Ram S Sakhare, Vivek B. Panchbhai, Vijayendra Swamy S. M.
Email(s):
moinattar@gmail.com
DOI:
10.52711/2231-5691.2026.00056 
Address:
Moein S Attar1*, Divya D. Bhandare2, Ram S Sakhare3, Vivek B. Panchbhai4, Vijayendra Swamy S. M.5
1Assistant Professor, Department of Pharmaceutical Chemistry, Channabasweshwar Pharmacy College (Degree), Latur, Kava Road, Basweshwar Chowk, Latur 413512, Maharashtra, India.
2Department of Pharmaceutical Chemistry, Channabasweshwar Pharmacy College (Degree), Latur, Kava Road, Basweshwar Chowk, Latur 413512, Maharashtra, India.
3Professor and Head, Department of Quality Assurance, Channabasweshwar Pharmacy College (Degree), Latur, Kava Road, Basweshwar Chowk, Latur 413512, Maharashtra, India.
4Professor and Head, Department of Pharmaceutical Chemistry, Channabasweshwar Pharmacy College (Degree), Latur, Kava Road, Basweshwar Chowk, Latur 413512, Maharashtra, India.
5Principal, Channabasweshwar Pharmacy College (Degree), Latur, Kava Road, Basweshwar Chowk, Latur 413512, Maharashtra, India.
*Corresponding Author
Published In:
Volume - 16,
Issue - 4,
Year - 2026
ABSTRACT:
This study details the development and rigorous validation of a novel, and stability-indicating analytical method (SIAM) using Reversed-Phase High-Performance Liquid Chromatography (RP-HPLC) for the estimation of dolutegravir in bulk and commercial tablet formulations. To ensure method robustness and other validation parameters as per regulatory authority’s guidelines an Analytical Quality by Design (AQbD) approach was implemented. A Central Composite Design (CCD) was utilized for systematically adjust critical method factors, leading to the selection of a highly efficient, buffer-free mobile phase consisting of methanol along with water in the proportion of 40:60, v/v. Chromatographic separation was achieved on a BDS C18 column with dimensions 250 mm × 4.6 mm, 5 µm where employed flow rate at 1.0 mL/min, detection by PDA detector at 257 nm. Under these optimized conditions, dolutegravir eluted rapidly with a retention time of just 2.448 minutes. The method demonstrated excellent linearity (R2 = 0.9995) in concentration range of 12.5 µg/mL to 75 µg/mL, alongside high sensitivity, marked by an 0.05 µg/mL LOD and 0.17 µg/mL LOQ. Furthermore, it exhibited outstanding precision (%RSD < 0.5%) and accuracy with an overall mean recovery of 99.35%. Comprehensive SIAM confirmed the method's power in forced degradation, successfully resolving intact active ingredient from degradants generated under acidic, alkaline, and oxidative stress conditions. Ultimately, this robust, sustainable, and cost-effective methodology offers a highly reliable tool for the routine quality control and comprehensive shelf-life monitoring of dolutegravir.
Cite this article:
Moein S Attar, Divya D. Bhandare, Ram S Sakhare, Vivek B. Panchbhai, Vijayendra Swamy S. M.. AQbD-Optimized Stability-Indicating HPLC Method for the Estimation of Dolutegravir. Asian Journal of Pharmaceutical Research. 2026; 16(4):385-0. doi: 10.52711/2231-5691.2026.00056
Cite(Electronic):
Moein S Attar, Divya D. Bhandare, Ram S Sakhare, Vivek B. Panchbhai, Vijayendra Swamy S. M.. AQbD-Optimized Stability-Indicating HPLC Method for the Estimation of Dolutegravir. Asian Journal of Pharmaceutical Research. 2026; 16(4):385-0. doi: 10.52711/2231-5691.2026.00056 Available on: https://www.asianjpr.com/AbstractView.aspx?PID=2026-16-4-3
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