Výsledky vyhledávání - "Velusamy B Subramanian"

Stability-Indicating RP-HPLC Method Development and Validation for Eltrombopag Olamine in the Presence of Impurities and Degradation Products. Robustness by Design of Expert Software

Autor: Rajeshwari Dandabattina, Velusamy B Subramanian, Karuna Sree Merugu, Haridasyam SharathBabu, Naresh Kumar Katari, Leela Prasad Kowtharapu

Publikováno v: Journal of AOAC INTERNATIONAL. 106:267-275

Background A simple and reliable HPLC method for determining impurities in eltrombopag olamine (ELO) film-coated tablets is not available. At the same time, there is no official monograph reported. The proposed research is targeted at the development

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ebe3f7dbc2c69cd5526c8139fca10b2d
https://doi.org/10.1093/jaoacint/qsac153

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A simple high‐performance liquid chromatography method development for Carbidopa and Levodopa impurities: Evaluation of risk assessment before method validation by Quality by Design approach

Autor: Velusamy B. Subramanian, Naresh Konduru, Naresh Kumar Katari, Rambabu Gundla, Thirupathi Dongala

Publikováno v: SEPARATION SCIENCE PLUS. 3:530-539

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::18fb1b5aa58d3dbcba179090884f2325
https://doi.org/10.1002/sscp.202000029

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Stability-indicating reversed-phase-HPLC method development and validation for sacubitril/valsartan complex in the presence of impurities and degradation products: Robustness by quality-by-design approach

Autor: Vijetha Ponnam, Govind Vyas, Vishnu Murthy Marisetti, Thirupathi Dongala, Velusamy B. Subramanian, Naresh Konduru, Naresh Kumar Katari

Publikováno v: Biomedical chromatography : BMCREFERENCES. 36(1)

According to current regulatory guidelines, a stability-indicating method has been developed to determine the impurities in sacubitril (SCB) and valsartan (VLS) tablet dosage forms and perform robustness studies using the design of experiments approa

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a3db2b41bf0288e091fb11e80425fd4c
https://pubmed.ncbi.nlm.nih.gov/34486750

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Stability‐indicating RP‐HPLC method development and validation for determination of nine impurities in apixaban tablet dosage forms. Robustness study by quality by design approach

Autor: Thirupathi Dongala, Sreekantha B. Jonnalagadda, Velusamy B. Subramanian, Naresh Kumar Katari

Publikováno v: Biomedical Chromatography. 34

A quality by design (QbD) based high-resolution HPLC method is described for determination of impurities in apixaban (APX) in the tablet dosage form. Employing a simple and stability-indicating HPLC method, nine known impurities were quantified with

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a3052dff123e29bf0e2755265a11a767
https://doi.org/10.1002/bmc.4719

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