Forced Degradation Behaviour with a Developed and Validated RP-UPLC Method for Estimation Lamivudine and Dolutegravir in Combined Pharmaceutical Dosage Form
Subramaniam Ananda Thangadurai
Department of Pharmaceutical Analysis, J. K. K Nattraja College of Pharmacy, (Affiliated by The Tamilnadu. N. Dr. M. G. R. Medical University, Chennai), Kumarapalayam - 638183, Tamil Nadu, India.
Dhanabalan Kamalakannan *
Department of Pharmaceutical Analysis, J. K. K Nattraja College of Pharmacy, (Affiliated by The Tamilnadu. N. Dr. M. G. R. Medical University, Chennai), Kumarapalayam - 638183, Tamil Nadu, India.
*Author to whom correspondence should be addressed.
Abstract
A simple, fast, precise, specific, and accurate reversed phase Ultra Performance Liquid Chromatographic (UPLC) method was developed and validated for the forced degradation studies of the Lamivudine and Dolutegravir in tablet dosage form. Chromatogram was run HSS C18 (2.6 x 50mm, 1.6µm). Mobile phases containing 70% 0.01N disodium hydrogen phosphate: 30% Methanol). The elution of analytes was achieved with a flow rate at 0.3 mL/min. Potassium dihydrogen phosphate was used as a buffer in this experiment. Temperature was maintained at 30°C. Optimized wavelength selected at 260nm. The detector response was linear in the concentration range of 25-150μg/mL respectively. Retention time of Lamivudine and Dolutegravir were found to be 1.408min and 1.739min. %RSD of the Lamivudine and Dolutegravir were and found to be 0.8 and 0.8. The % recovery was obtained as 100.39% and 100.37% for Lamivudine and Dolutegravir. LOD, LOQ values obtained from regression equations of Lamivudine and Dolutegravir were 0.41, 1.25 and 0.09, 0.26. Regression equation of Lamivudine was y = 24270x + 12218 and for Dolutegravir was y = 34783x + 1060. Since retention times and run times were reduced, the method established was easy and premium and it could be used in periodic quality control tests in industries.
Keywords: Lamivudine, dolutegravir, RP-UPLC, forced degradation