ABSTRACT
OBJECTIVE: To develop an analytical method for determination of unknown residual solvents in solid drug products by GC-MS in order to meet the need of supervision. METHODS: Fifty residual solvents including benzene, carbontetrachloride, 1, 2-di-chloroethane, 1, 1, 1-trichloroethane, acelonitrile, chlorobenzene, acetone, etc, were determined by GC/MS using selected ion monitoring (SIM) mode. RESULTS: Good linearity was obtained with correlation coefficients of more than 0.9975 for all the solvents. The average recoveries of the quality control samples at low, middle and high concentrations were from 88.8% to 109.8% and the relative standard deviations (RSDs) were lower than 11.6%. The limits of detection (TODs) were in the range of 0.00003-0.3μg·mL-1, while the limits of quantitation (LOQs) were in the range of 0.00009-1 μg ·mL-1. CONCLUSION: The method is simple, rapid, sensitive and accurate, and can be used for the simultaneous determination of 50 residual solvents in solid preparations such as tablets and capsules.