Journal ArticleOPEN ACCESS

Stability Indicating RP-HPLC Method Development and Validation of Related Substances for Dolutegravir Dispersible Tablets

  • Velusamy M
  • Nagarajan S
  • Rathinam V
  • et al.
Pharmacophore (2022) 13(2) 56-64
DOI: 10.51847/2marzxsil2
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Abstract

A simple, rapid, and robust reverse phase HPLC method was developed and validated for the determination of related substances for Dolutegravir dispersible tablets 10mg. The primary goal of this research is to develop and validate a new RP-HPLC method for validating the amount of Impurity B (degradation impurity) as a related substance following USP guidelines. Dolutegravir and its impurities were separated using chromatographic conditions on a Phenyl-Hexyl (250 × 4.6 mm), 5µ column w

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Velusamy, M., Nagarajan, S., Rathinam, V., & Murali, M. (2022). Stability Indicating RP-HPLC Method Development and Validation of Related Substances for Dolutegravir Dispersible Tablets. Pharmacophore, 13(2), 56–64. https://doi.org/10.51847/2marzxsil2

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