• Tanguturi Sai Nikitha
• S. Lakshmi Naga Aparna
• U. Mohan Kumar
• Chukka Mokshavathi
• Palloli Sravanthi

A simple, rapid, precise, and accurate reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Dolutegravir and Rilpivirine in bulk and pharmaceutical dosage forms. Chromatographic separation was achieved using an INERTSIL ODS column (200 mm × 4.6 mm, 5 μm particle size) with a mobile phase consisting of methanol and phosphate buffer (pH 3.5) in the ratio of 60:40 v/v, delivered at a flow rate of 1.5 mL/min. Detection was carried out at 230 nm using a UV detector. The retention times for Dolutegravir and Rilpivirine were found to be 3.4 minutes and 4.3 minutes, respectively. The method demonstrated excellent linearity over the concentration ranges of 50–250 µg/mL for Dolutegravir and 25–125 µg/mL for Rilpivirine, with correlation coefficients (r²) of 0.999 for both drugs. System suitability parameters such as theoretical plates and tailing factor were within acceptable limits. The %RSD values for precision and intermediate precision were below 2%, indicating high repeatability and reproducibility. The LOD and LOQ were found to be 3.08 µg/mL and 10.10 µg/mL for Dolutegravir and 3.0 µg/mL and 10.02 µg/mL for Rilpivirine, respectively. Forced degradation studies confirmed the method’s stability-indicating capability under acidic, basic, oxidative, thermal, and photolytic conditions. This validated RP-HPLC method is suitable for the routine quality control and stability analysis of Dolutegravir and Rilpivirine in bulk drug and pharmaceutical formulations.

Dolutegravir, Rilpivirine, Methanol, Phosphate Buffer, Method Validation.

"Validated Stability-Indicating RP-HPLC Method for the Simultaneous Quantification of Antiretroviral Agents in Bulk and Pharmaceutical Dosage Forms", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.12, Issue 4, page no.n72-n79, April-2025, Available :http://www.jetir.org/papers/JETIR2504D09.pdf

"Validated Stability-Indicating RP-HPLC Method for the Simultaneous Quantification of Antiretroviral Agents in Bulk and Pharmaceutical Dosage Forms", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.12, Issue 4, page no. ppn72-n79, April-2025, Available at : http://www.jetir.org/papers/JETIR2504D09.pdf