Abstract：Objective To establish the gas chromatography for the determination of o/p-toluenesulfonamide in saccharin sodium. Methods DB-17MS chromatographic column was applied, the initial temperature was set at 180 ℃for 20 min, and then heated up to 260℃at 10℃/ min and maintained for 32 min. Results The peak area of o-toluenesulfonamide in 11.80-223.60 μg/ml (r=1) showed a good linear relationship with the concentration, the average sample recovery rate was 96.58%, and the RSD was 5.73% (n=6).The peak area of p-toluenesulfonamide in 10.15-203.00 μg/ml(r=1) showed a good linear relationship with the concentration, the average sample recovery rate was 103.99%, and the RSD was 2.83% (n=6).The content of o/p-toluenesulfonamide in saccharin sodium in 6 batches was not detected because the results were lower than the detection limit, which met the requirements of the pharmacopoeia. Conclusion The GC for the determination of toluenesulfonamide in saccharin sodium is simple and accurate, and can be used as a quality evaluation standard for saccharin sodium.
张东阁； 郭艳玲； 杨宇杰. 气相色谱法测定糖精钠中邻、对甲苯磺酰胺含量[J]. 中国当代医药, 2020, 27(15): 31-35.
ZHANG Dong-ge； GUO Yan-ling； YANG Yu-jie. Content determination of o/p-toluenesulfonamide in saccharin sodium by the gas chromatography. 中国当代医药, 2020, 27(15): 31-35.
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