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A simultaneous determination of related substances by high performance liquid chromatography in a drug product using quality by design approach

Autor: Gautam Samanta, Trupti Tol, Nilesh Kadam, Anita Desai, Nilesh Raotole

Publikováno v: Journal of Chromatography A. 1432:26-38

The combination of Abacavir, Lamivudine and Dolutegravir is an anti-retroviral formulation that displays high efficacy and superiority in comparison to other anti-retroviral combinations. Analysis of related substances in this combination drug produc

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c09113adde1d239ab0355299d2f4c97b
https://doi.org/10.1016/j.chroma.2015.12.080

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Optimization of a liquid chromatography method for the analysis of related substances in daclatasvir tablets using design of experiments integrated with the steepest ascent method and Monte Carlo simulation

Autor: Savita Gorad, Amol Kulkarni, Avinash Jagdale, Avinash Kasbale, Trupti Tol, Anita Desai, Harshad Tawde, Gautam Samanta

Publikováno v: Journal of Pharmaceutical and Biomedical Analysis. 178:112943

Analytical method for the determination of related substances (RS) in Daclatasvir tablets was optimised using quality by design (QbD) approach. Seven degradants (each more than 1.0%) generated during oxidation study, adversely affected the selectivit

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::651de58c9c3920b15b217621e99aa10f
https://doi.org/10.1016/j.jpba.2019.112943

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