A Novel Analytical Method for the Determination of Residual Solvents in Mesalamine Delayed Release Tablets by GC-HS Method
DOI:
https://doi.org/10.37285/ijpsn.2022.15.3.5Abstract
Background: Residual solvents and organic volatile impurities are monitored using Head Space Gas Chromatography present in pharmaceutical samples. Mesalamine is a 5-aminosalicylic acid 5-ASA based agent which is used to treat adults with ulcerative colitis.
Objective: In this study, an attempt was made to analyze the residual organic solvents such as isopropyl alcohol and dichloromethane present in Mesalamine Delayed-Release Tablets by headspace gas chromatography (HS-GC).
Method: The carrier gas streamed was nitrogen, the method was developed and optimized by using a DB-624(60 m × 0.53 mm × 3.0 µm) column coupled with a flame ionization detector. A capillary column consisting of 6 % cyanopropylphenyl - 94 % dimethyl polysiloxane was employed as the stationary phase. An injector temperature of 200°C was programmed to prevent degradation.
Results: A temperature of 40°C was set as the initial oven temperature for a period of 10 min and set at a rate of 20°C min−1 and monitored at a final temperature of 220°C for 5 min. Chloroform and N, N-dimethylacetamide was selected as the sample solvent. The validation studies were performed with regard to International Council for Harmonization (ICH) Q2 guidelines for the validation of analytical experiments.
Conclusion: All the validation parameters complied with the acceptance criteria. Hence, the optimized method developed and validated can be utilized for the concurrent estimation of residual solvents in tablet formulations.
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Keywords:
GC-HS, Isopropyl Alcohol, Dichloromethane, Residual Solvents, Mesalamine Delayed Release Tablets
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References
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