The gas chromatography method was developed for the determination of ethylene glycol, diethylene glycol and triethylene glycol in poloxamer 188 to provide scientific basis for the quality control. The samples was separated on column VF-17ms(30 m×0. 53 mm, 1. 0 μm)with temperature programming, inlet temperature was 270 °C, detector temperature was 290 °C and the split ratio was 10 ∶1. The method showed great linearity over the range of 6-15 μg/mL(r≥0. 999). The injection precision(n=8)of the three residual impurities were 3. 3%, 3. 0%, 2. 3% and the average recoveries were 99. 05%(RSD=2. 9%, n=9), 102. 20%(RSD=4. 0%, n=9), 101. 91%(RSD=3. 1%, n=9), respectively. The analytical method is specific, accurate and sensitive, which is suitable for the determination of ethylene glycol, diethylene glycol and triethylene glycol in poloxamer 188, providing reference and guidance for the production and quality control of poloxamer 188.

To improve the current quality standards of polysorbate 80 and provide reference recommendations for the revision of the quality standards of polysorbate 80 in the fourth part of China Pharmacopoeia(2015 Edition). A total of 16 batches of polysorbate 80 samples from 6 domestic and foreign production companies were studied, optimize the detection method for some impurities. Adjust the split ratio of the ethylene oxide and dioxane check items, and appropriately increase the concentration of the reference solution solution and change the solvent. In the ethylene glycol and diethylene glycol items, the concentration of the reference solution and the internal standard solution were appropriately increased. The infrared identification and the triethylene glycol check items were added to the quality standards, and we carry out corresponding methodological investigation on the improved method. The results showed that the improved methods had good specificity, precision, linearity and recovery rate. The improved quality standard is more suitable for the detection of polysorbate 80, and can increase the quality standards of polysorbate 80 from safety and standardization.

Objective:To develop and validate gas chromatographic methods for the determination of residual benzene in carbomer copolymer,carbomer homopolymer and carbomer interpolymer,to address the issues of the current method in the Chinese Pharmacopoeia in the actual detection process,such as low sensitivity and poor repeatability of benzene detection in the mixed reference solution,and to optimize and improve the current stand-ards for series of carbomer pharmaceutical excipients.Methods:Samples were separated on a column DB-624(30 m ×0.530 mm,3.00 μm)with temperature programming,the inlet temperature of 140 ℃,the detector tem-perature of 250 ℃,and the split ratio of 5∶1.The external standard method was adopted for the quantitative deter-mination of residual benzene.Results:The linearity was great across the range of 0.04-1.00 μg·mL-1(r=0.996 8),the injection precision of benzene was 6.8％(n=6),and the average recovery rate was 96.89％(RSD=8.1％,n=9).Conclusion:The gas chromatographic method established in this research is more specif-ic,with higher accuracy and precision compared to the current method in the Chinese Pharmacopoeia.This optimized method is more suitable for the determination of residual benzene content in carbomer copolymer,car-bomer homopolymer and carbomer interpolymer,providing reference and guidance for the quality management and the control of carbomer.