Analytical Method Development and Validation for the Quantification of Triethylamine Solvent in Piperaquine Phosphate API by Using Headspace Gas Chromatographic Technique

Autor: Phadke, Rajendra, Gosar, Amit, Swapnil Patil, Lxamikant Rawool
Jazyk: angličtina
Rok vydání: 2020
Předmět:
ISSN: 0731-7085
DOI: 10.5281/zenodo.3687373
Popis: Residual solvents in pharmaceutical samples are monitored using gas chromatography with head space technique. Based on good manufacturing practices and regulatory requirement measuring a residual solvent is mandatory for the release testing of all active pharmaceutical ingredients (API). The analysis of residual organic solvents Triethylamine in Piperaquine Phosphate, an active pharmaceutical ingredient was investigated and quantified by gas Chromatograph.The Head space gas chromatography (GC-HS) method described in this investigation utilized a DB-1, column with dimension 30m X 0.32mm ID X 3.0µm. The initial oven temperature was set at 40°C for 8 min and programmed at a rate of 20°C min−1 to a final temperature of 200°C for 4 min. Nitrogen gas was used as a carrier gas. The method was validated to be specificity, linearity, and precise, sensitive, rugged and showed excellent recovery.
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