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ORIGINAL ARTICLE
Year : 2022  |  Volume : 14  |  Issue : 4  |  Page : 209-215

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


1 Department of Pharmaceutical Analysis, Raghavendra Institute of Pharmaceutical Education and Research – Autonomous, Ananthapuramu, Andhra Pradesh, India
2 Department of Chemistry, Jawaharlal Nehru Technological University - OTPRI, Ananthapuramu, Andhra Pradesh, India

Correspondence Address:
K V Lalitha
Department of Pharmaceutical Analysis, Raghavendra Institute of Pharmaceutical Education and Research – Autonomous, Ananthapuramu, Andhra Pradesh
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ajprhc.ajprhc_38_22

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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.


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