A Stability Indicating Novel Analytical Method for the Determination of Lamivudine and Dolutegravir in Bulk and its Tablets Using Reverse Phase High-Performance Liquid Chromatography

Abstract

Aim: A simple and sensitive analytical method was developed to simultaneously estimate lamivudine (LAM) and dolutegravir (DOL), anti-retroviral drug combination in bulk and dosage forms. Materials and Methods: Separation of analytes was done on a BEH Shield RP18 (2.1 mm × 100 mm × 1.7 mm, 5 μm Particle size) using sodium dihydrogen phosphate pH 4.9 adjusted with orthophosphoric acid: Methanol (60:40, %v/v) as mobile phase pumped at 1.0 ml/min. A photodiode array detector was used to find the detection wavelength at an isosbestic point of 292 nm while maintaining the column temperature at 30°C. With a total run period of 8 min, the mobile phase was utilized as a diluent. The International Council on Harmonization guidelines were followed in the method's validation. The method's capacity to indicate stability was confirmed by experiments on forced degradation. Results: LAM and DOL eluted at 2.88 and 3.83 min, respectively. Both the drugs exhibited excellent linearity between 105.00–315.00 and 17.50–52.50 μg/ml for LAM and DOL, respectively. The LOD and LOQ were found to be 4.51 and 15.03 μg/ml for LAM and 5.82 and 19.41 μg/ml for DOL, respectively, which are very minute concentrations. Conclusion: The method was therefore found to be quite sensitive. The proposed high-performance liquid chromatography technique was thereby sensitive, reproducible, accurate, and reliable for the measurement of LAM and DOL.

Application of signal processing techniques for the spectroscopic analysis of dolutegravir and lamivudine: a comparative assessment and greenness appraisal

“…Limited research has been conducted on the analytical methodologies for determining the combination of DTG and LMV in their combined dosage forms. Previous studies have primarily utilized chromatographic separation techniques, including high-performance liquid chromatography (HPLC) and liquid chromatography-tandem mass spectrometry (LC–MS/MS), to analyze these drugs [ 6 – 8 ]. However, it is important to note that these chromatographic methods do possess limitations such as environmentally unfriendly practices due to the significant use of organic solvents and time-consuming optimization processes.…”