DEVELOPMENT OF RP-HPLC, HPTLC AND UV SPECTROPHOTOMETRY METHODS FOR QUANTIFICATION OF DOLUTEGRAVIR SODIUM IN BULK AND FORMULATION

In the present study, three quantitative methods for dolutegravir sodium (DTG) by RP-HPLC, HPTLC and UV spectrophotometry were developed. RP-HPLC comprises separation on a C4 column by gradient elution using mobile phase consisting of sodium dihydrogen ortho phosphate (pH 3; 10 mM) and acetonitrile at a flow rate of 1 mL/min. The method was successfully applied to study stability under different stress conditions, as recommended by ICH guidelines. In HPTLC, separation and quantitation depends on aluminium plates pre-coated with silica gel 60 F254 as a stationary phase using chloroform: toluene: methanol: acetic acid (8:1:1:0.1, V/V/V/V) as mobile phase followed by densitometric measurement of the bands at 258 nm. In UV spectrophotometry, DTG was quantified by measuring the absorbance at 258 nm using methanol as solvent. The developed methods were validated as per ICH guidelines. The validated methods were successfully applied for determination of the DTG in pharmaceutical formulatios.