• Mr. Ravindra Motiram Amale
• Dr. Sonali A. Waghmare

Several spectrophotometric and HPLC methods have been described for the determination of dolutegravir in drugs and in pharmaceutical dosage forms. Therefore, a novel, sensitive, convenient, and robust reversed-phase high-performance liquid chromatography method for the determination of dolutegravir in bulk drug and tablet formulation was developed and validated in this study. In the RP-HPLC method, methanol and 0.025% TFA (80:20% v/v) were used as mobile phases, at a flow rate of 1.0 mL/min, on an HPLC system containing a UV detector with Openlab EZchrome and Kromasil C18 software. 250 mm x 4.6 mm, 5 µm. Detection was performed at 258 nm. The method gave a suitable retention time, i.e. 3.77 min for Dolutegravir. The results of the analysis in the method were validated in terms of Filtration study, Solution stability, specificity, Linearity, accuracy, precision (Repeatability and medium precision), limit of detection, limit of quantification and robustness. A simple and accurate method was developed for the determination of dolutegravir in the form of bulk drug and tablets. The method requires regular reagents to perform analysis and also less time consuming, it can be routinely performed in industry for routine analysis of bulk drug and marketed Dolutegravir.

RP-HPLC, Dolutegravir Sodium, Methanol Method Development, Validation.

"RP-HPLC METHOD FOR ESTIMATION OF DOLUTEGRAVIR SODIUM IN BULK DRUG AND DOSAGE FORM INCLUDING SOLUTION STABILITY AND FILTRATION STUDY AS PER ICH Q2R1 GUIDELINE ", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.10, Issue 5, page no.b83-b102, May-2023, Available :http://www.jetir.org/papers/JETIR2305110.pdf

"RP-HPLC METHOD FOR ESTIMATION OF DOLUTEGRAVIR SODIUM IN BULK DRUG AND DOSAGE FORM INCLUDING SOLUTION STABILITY AND FILTRATION STUDY AS PER ICH Q2R1 GUIDELINE ", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.10, Issue 5, page no. ppb83-b102, May-2023, Available at : http://www.jetir.org/papers/JETIR2305110.pdf