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Analytical method development and validation for estimation of dolutegravir in tablet dosage form

A. Pate,V. Barge,Amit J. Kasabe,Vikram Kerle,Onkar Kulkarni

Published 2022 in International Journal of Health Sciences

ABSTRACT

A simple, specific, accurate, and precise reverse phase high performance liquid chromatography method was developed and validated to analyse Dolutegravir Sodium bulk dosage form. Using Princeton C18 HPLC column separation was carried out. This was maintained at 25ºC temperature. Shimadzu LC -20A prominence with LC solution softwarering separation mobile phase consist of Methanol: Water (0.1% OPA) in ratio of  80:20 v/v was delivered at a flow rate of 1mL/min. Using UV detector analysis was carried out at the wavelength 254 nm. RP-HPLC method was validated by using various parameter like system suitability, linearity, specificity, precision, limit of detection, limit of quantification and robustness. The RP-HPLC method was found to be linear over the concentration range from 10-60 µg/mL (r2 =0.9998). Retention time for bulk Dolutegravir Sodium was found to be 4.383 min. LOQ of method was 1.3274 µg/mL and LOD 0.4380 µg/mL. Thus the developed RP-HPLC method was found to be robust which can be applied for the regular analysis of Dolutegravir Sodium in the bulk as well as pharmaceutical dosage form. 

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