Journal of AOAC International · 2021
Simultaneous Determination of Nine Residual Solvents in Sorafenib Tosylate by Gas Chromatography.
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Sun Rong, Hu Chengran, Dou Qian, Luan Libiao
Аннотация
BACKGROUND: Direct injection gas chromatography is convenient and quick. The residual solvent with a higher boiling point can be measured by using direct inhection gas chromatography. This method could be developed for residual solvents analysis of sorafenible tosylate.
OBJECTIVE: In the present investigation, the injection method was developed and validated for the detection and quantification of residual solvents in sorafenib tosylate.
METHOD: The nine kinds of residual solvents were separated using direct injection gas chromatographic technology, and a quantitative analysis was performed. Analytical performance of the proposed injection method was validated as per the defined guidelines with respect to linearity, accuracy, precision, robustness, and specificity.
RESULTS: Under the optimized conditions, simultaneous separation and determination of nine kinds of residual solvents, including methanol, acetonitrile, ethyl acetate, tetrahydrofuran, chlorobenzene, toluene, acetone, dichloromethane, and N, N-dimethylformamide were carried out using a DB-WAXETR polyethylene glycol Inertap Pure-WAX column (30 m × 0. 32 mm × 0.25 µm) for separation. The calibration plot was found to be linear, accurate, precise, robust, and specific for direct injection gas chromatography. The residual solvents in sorafenib tosylate were quantified by the developed method.
CONCLUSIONS: The present method was successfully applied for analysis of residual solvents in sorafenib tosylate. Similarly, the method can be used for quality control and stability testing of other medicines.
HIGHLIGHTS: A validated GC assay for the combined analysis of the nine solutions which offered a reference method for the detection of residual solvents in other medicines.
OBJECTIVE: In the present investigation, the injection method was developed and validated for the detection and quantification of residual solvents in sorafenib tosylate.
METHOD: The nine kinds of residual solvents were separated using direct injection gas chromatographic technology, and a quantitative analysis was performed. Analytical performance of the proposed injection method was validated as per the defined guidelines with respect to linearity, accuracy, precision, robustness, and specificity.
RESULTS: Under the optimized conditions, simultaneous separation and determination of nine kinds of residual solvents, including methanol, acetonitrile, ethyl acetate, tetrahydrofuran, chlorobenzene, toluene, acetone, dichloromethane, and N, N-dimethylformamide were carried out using a DB-WAXETR polyethylene glycol Inertap Pure-WAX column (30 m × 0. 32 mm × 0.25 µm) for separation. The calibration plot was found to be linear, accurate, precise, robust, and specific for direct injection gas chromatography. The residual solvents in sorafenib tosylate were quantified by the developed method.
CONCLUSIONS: The present method was successfully applied for analysis of residual solvents in sorafenib tosylate. Similarly, the method can be used for quality control and stability testing of other medicines.
HIGHLIGHTS: A validated GC assay for the combined analysis of the nine solutions which offered a reference method for the detection of residual solvents in other medicines.