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Residual solvent determination by head space gas chromatography with flame ionization detector in itraconazole API.
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| Author:
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GAMPA NAGAMALLESWARI, M.S.UMA SHANKAR
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| Abstract:
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Residual solvents are not desirable substances they are monitored using gas chromatography with head space based on good manufacturing practices. Measuring residual solvents is mandatory for the release testing of all active pharmaceutical ingredients was investigated. The head space gas chromatography method described in this investigation utilized a 30m x 0.530mm x3.0µ, DB-624 Capillary Column. The injector temperature was set at 2000C. To prevent degradation. The initial oven temperature was set at 900C for 5 min and programmed at a rate of 400C a final temperature of 2200C for 5 min. Nitrogen was used as carrier gas. The simple solvent selected was benzyl alcohol. The method was validated to be specific, linear, precise, sensitive, rugged, and showed excellent recovery.
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| Keyword:
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Residual solvents, Gas chromatography, Benzyl alcohol, Itraconazole.
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| EOI:
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-
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| DOI:
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https://doi.org/10.31838/ijpr/2022.14.01.023
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| Download:
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Request For Article
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