Determination of palmitic acid and stearic acid migration of docetaxel injection in brominated butyl rubber stopper partially covered with polytetrafluoroethylene film for injection
Determination of palmitic acid and stearic acid migration of docetaxel injection in brominated butyl rubber stopper partially covered with polytetrafluoroethylene film for injection
Objective:To establish a gas chromatographic method for determining the migration of palmitic acid and stearic acid in the compatibility study of docetaxel injection with topically coated polytetrafluoroethylene film bromobutyl rubber stopper for injection.Methods:A DB-FFAP capillary column was used,with programmed temperature increase:170℃held for 2 min,10℃/min rate increase to 240℃,held for 11 min.The flow rate was 2 ml/min.The inlet temperature was 220℃,and the FID detector temperature was 260℃.Results:Methyl palmitate and methyl stearate showed good linearity in the concentration ranges of 0.195 9～195.86 μg/ml(r=0.999 9)and 0.191 8～191.85 μg/ml(r=0.999 8),respectively;the spiked recoveries were 96.66%(RSD was 0.42%)and 96.53%(RSD was 0.42%)for methyl palmitate and methyl stearate,respectively.The detection limits for methyl palmitate and methyl stearate were 58 and 98 ng/ml,respectively.The migration of stearic acid and palmitic acid at five time points in three batches of samples ranged from 15.21 to 26.35 μg/ml and 12.82 to 16.26 μg/ml,respectively.Conclusion:The method is accurate and reliable and can be used to determine the migration of palmitic acid and stearic acid of docetaxel injection in brominated butyl rubber stopper partially covered with polytetrafluoroethylene film for injection.
维普
万方数据