Analytical Method Development for the Determination of Residual solvents Analysis in Trabectedin drug substance by Head space Gas chromatography [HSGC]

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B.Prathima, M.Vijey Aanandhi, N.K Srinivasa Rajagopalachari


Aim and Objective: The aim of the work is focused on the optimization of the GC method for the determination of Residual solvents Analysis in Trabectedin drug substance by Head space gas chromatography [HSGC]. For each drug product the analysis of Residual solvent content is an important factor and it should be performed in all the pharmaceutical industries in order to avoid or overcome the toxicity which can cause harm to humans. Generally Gas chromatography with head space is used to determine the residual solvents because of its high grade separation abilities and low limit of detection. Method: The Chromatographic separation was performed using GC with Flame Ionization detector [FID] using Helium as “Carrier Gas” with CP Select -624 [ 60m X0.32mm, 1.8µm film thickness] column  and Split ratio 10:1 with N-Methyl-2-pyrrolidone as diluent. Results: All the Solvents [Methanol, Ethanol, Hexane, Dichloromethane, Isopropyl ether, Ethyl acetate, Acetonitrile, Tetrahydrofuran, Acetone, Isopropyl Alcohol] mentioned under ICH Q3C were eluted correspondingly at the individual retention time and the method shall be validated as per ICH Q2R1 Guideline. Conclusion: The method has been successfully evaluated and developed for the analytical applications.

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