Chaotropic Chromatography Method for Simultaneous Determination of Lamivudine, Abacavir and Dolutegravir in Pharmaceutical Formulations

In the pharmaceutical field, quality control professionals often face challenges when analyzing active substances that contain basic ionizable groups. One of the strategies available to address these issues is chaotropic chromatography. In this context, a novel chaotropic chromatography method for the simultaneous separation and determination of three antiretrovirols, Lamivudine (LMV), Abacavir (ABC) and Dolutegravir (DTG) in pharmaceuticals formulations has been developed and validated. An effective separation was achieved on Pentafluorophenyl propyl (5 F-PHP) column maintained at 40 °C. The used mobile phase, comprised of 50 mM sodium perchlorate buffer (pH 2.8 ± 0.05) containing 0.1% (v/v) of triethylamine and acetonitrile, was delivered with gradient elution at flow rate of 1.0 mL/min. The developed method was validated according to a recent validation strategy, the accuracy profile methodology. Considering the resulted validation data, specificity, trueness, fidelity and accuracy of the method were confirmed. The LOD values of the compounds of interest were found to be 0.21, 0.47 and 0.09 µg/mL for LMV, ABC and DTG respectively. The developed and validated method was successfully applied to study the dissolution profile of DTG in two drugs formulation using two different media generally used in the dissolution test.