RP-HPLC AND HPTLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF DOLUTEGRAVIR IN BULK AND TABLET DOSAGE FORM

• Published in: Indian drugs Vol. 56; no. 5; pp. 30 - 38
• Main Authors: Ghante, M. R., Sawant, S. D, Undre, M., Jagtap, S. G, Kulkarni, P., Nikam, V. S
• Format: Journal Article
• Language: English
• Published: 28.05.2019
• ISSN: 0019-462X
• DOI: 10.53879/id.56.05.11288

Dolutegravir (DTG) is a second-generation integrase strand transfer inhibitor (INSTI), antiretroviral drug. RP-HPLC and HPTLC methods have been developed and validated for DTG in bulk and tablet dosage form. In HPLC method, analysis was carried out on C-18 column using a mixture of acetonitrile: phosphate buffer (pH 7.0) in the ratio of (90:10 V/V) as mobile phase at the flow rate 1 mL/min at 261 nm. The method was found to be linear in the concentration range 10-70 μg/mL. Peak for DTG was observed at 2.8 ± 0.1 minutes. For HPTLC method proper resolution was achieved with toluene: methanol: formic acid 7:3:0.1(V/V/V) as the mobile phase at 334 nm. HPTLC method was found to be linear in concentration range of 200-600 ng/band. Rf value of DTG was found to be 0.496 ± 0.0055. Developed methods were validated as per ICH guidelines Q2(R1) and were found to be accurate, precise, simple and robust.