Stability Indicating Method Development For Estimation Of Dolutegravir (Dlt) And Lamivudine (Lam) By Hplc
Year: 2026
Type: article
Abstract: A stability-indicating HPLC method was developed and validated for the simultaneous estimation of Dolutegravir (DLT) and Lamivudine (LAM) in pharmaceutical formulations. The method demonstrated excellent linearity for DLT (1–5 µg/mL, r² = 0.9991) and LAM (10–50 µg/mL, r² = 0.9996). System suitability parameters, including retention time, theoretical plates, and tailing factor, were within acceptable limits, indicating precise and reliable chromatographic performance. Accuracy studies showed mean recoveries of 97.97–98.54% for DLT and 98.32–99.06% for LAM with %RSD <1%. Precision, assessed through repeatability, intermediate precision, analyst-to-analyst variation, and reproducibility, exhibited %RSD values <2%, confirming robustness. The method was successfully applied to commercial tablet formulations, and forced degradation studies revealed susceptibility to acidic, alkaline, oxidative, and photolytic conditions, demonstrating the stability-indicating nature of the method. The developed method is accurate, precise, sensitive, and suitable for routine quality control and stability studies of DLT and LAM.
Authors: Pradeep Mishra, Sanjay Bhawar
Institution: Bhagwant University
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: bronze
OpenAlex ID: W7150890489