Method Development and Validation for the Determination of Residual Solvents in Racecadotril by Gas Chromatography

Reddy Sattineni, Sirisha (2021) Method Development and Validation for the Determination of Residual Solvents in Racecadotril by Gas Chromatography. Current Pharmaceutical Analysis, 17 (9). pp. 1232-1239.

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Abstract

The presence of residual solvents in pharmaceuticals can be a potential risk factor to human health because of its toxicity. Gas chromatography is used for its excellent separation abilities and lower limit of detection. Racecadotril, an antidiarrheal drug, is reported having four residual solvents, namely n-Hexane, isopropyl alcohol, toluene, and dimethylformamide. Estimation of the amount of these solvents in active pharmaceutical ingredients to ensure that they are within the permissible limits as per ICH guidelines is necessary.

Item Type: Article
Uncontrolled Keywords: Racecadotril; Analytical method; Residual solvents; Gas chromatography; Method validation; Carcinogenic
Subjects: Pharmacy > MCOPS Manipal > Pharmaceutical Chemistry
Depositing User: KMC EPrints Administrator
Date Deposited: 26 Jan 2022 09:06
Last Modified: 26 Jan 2022 09:06
URI: http://eprints.manipal.edu/id/eprint/158172

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