Gas Chromatographic Assessment of Residual Solvents Present in Excipient-Benzyl Alcohol

Abstract

Purpose: This article describes a simple and rapid gas chromatographic method for identification of residual solvents present in benzyl alcohol. Benzyl alcohol is used in foods and pharmaceutical products. The organic solvents such as benzene, chlorobenzene and toluene are frequently used in manufacturing of benzyl alcohol. Even after such manufacturing process, some solvents still remain in small quantities. Methods: Method for the quantification of residual solvents present in benzyl alcohol was done by gas chromatography with flame ionization detector and utilizes the Agilent 7700 with FID (DB-624, 30 m × 0.53 mm, 3 μ) capillary column, nitrogen as carrier gas with a flow rate of 2.5 ml mn-1. The critical experimental parameters such as oven temperature, zero air, make up flow; injection volume, split ratio and the selection of diluent were studied and optimized. Results: The retention time of various residual solvents taken individually and in spiked standard solutions were determined as 8.824, 13.467 and 11.461 min for benzene, chlorobenzene and toluene respectively. The proposed method was applied for the quantification of residual solvents present in marketed benzyl alcohol and was statistically validated as per standard guidelines. Conclusion: The results obtained from validation proved that the proposed method was scientifically sound. The proposed method was fruitfully applied for the quantification of residual solvents (which are involved in the manufacturing process) present in benzyl alcohol.