摘要
目的:分析超高效液相色谱法测定紫杉醇注射液中有关物质的应用价值。方法:选择高效液相色谱仪、全自动进样器、高灵敏光纤型紫外检测器等设备,应用高效液相色谱法进行测定,流速为每分钟0.6mL,流动相为水和乙腈。色谱柱:流动相A为水,B为乙腈梯度洗脱(5分钟以内浓度为40%,5~11分钟浓度为40%~80%;10~11分钟浓度为80%);检测波长设置为227nm,柱温设置为40℃,流速为每分钟0.6mL。结果:紫杉醇具有不稳定性,在各种降解条件下,实施降解处理,测定降解杂质不干扰目标,在光照条件下,以及碱条件下,会增加杂质数量和杂质质量,在酸、光照与碱条件下,原料峰值面积会降低90%左右,不同杂质峰之间分离良好。原有量为1.5μg/mL,加入量为0.49μg/mL,则测得量为1.99μg/mL,回收率为99.3%,标准偏差为2.95%。原有量为0.98μg/mL,测得量为2.46μg/mL,回收率为99.3%,标准偏差为2.38%。原有量为1.5μg/mL,加入量为1.45μg/mL,测得量为2.94μg/mL,回收率为99.6%,标准偏差为1.5%。波长为225nm,标准偏差为0.89%,杂质个数为5个;温度为38℃,标准偏差为0.89%,杂质个数为5个;流速为0.54mL/min,标准偏差为2.49%,杂质个数为5个;色谱柱为1个,标准偏差为1.79%,杂质个数为5个。结论:通过采用超高液相色谱法,能够在短时间内,准确检查出紫杉醇注射液中的物质。
Objective:To analyze the application value of ultra-high performance liquid chromatography(UHPLC)in the determination of related substances in paclitaxel injection.Methods:UHPLC was used for determination with high performance liquid chromatograph,fully automatic sampler,and high sensitive fiber optic UV detector.The flow rate was 0.6mL/min,and the mobile phase was water and acetonitrile.Chromatographic column:A is water,B is acetonitrile gradient elution(concentration within 5 minutes is 40%,5-11 minutes concentration is 40%-80%;10-11 minutes concentration is 80%);the detection wavelength was set at 227nm,the column temperature was set at 40°C,and the flow rate was 0.6mL/min.Results:Paclitaxel is unstable.Under various degradation conditions,degradation impurities do not interfere with the target.Under illumination and reduced conditions,the number and quality of impurities increase.Under acid,illumination,and alkaline conditions,the peak area of raw materials decreases by about 90%.The original amount is 1.5μg/mL,the added amount is 0.49μg/mL,and the measured amount is 1.99μg/mL,with a recovery rate of 99.3%and a standard deviation of 2.95%.The original amount is 0.98μg/mL,the measured amount is 2.46μg/mL,with a recovery rate of 99.3%and a standard deviation of 2.38%.The original amount is 1.5μg/mL,the added amount is 1.45μg/mL,and the measured amount is 2.94μg/mL,with a recovery rate of 99.6%and a standard deviation of 1.5%.The wavelength is 225nm,the standard deviation is 0.89%,and the number of impurities is 5;the temperature is 38°C,the standard deviation is 0.89%,and the number of impurities is 5;the flow rate is 0.54mL/min,the standard deviation is 2.49%,and the number of impurities is 5;there is one chromatographic column,the standard deviation is 1.79%,and the number of impurities is 5.Conclusion:Ultra-high performance liquid chromatography can accurately detect the substances in paclitaxel injection in a short time.
作者
吴姗娜
卢桂清
Wu Shan-na;Lu Gui-qing(First Affiliated Hospital of Xiamen University,Xiamen 361000,China)
出处
《北方药学》
2023年第9期8-10,共3页
Journal of North Pharmacy
关键词
超高效液相色谱法
紫杉醇注射液
相关物质
High-performance liquid chromatography
paclitaxel injection
related substances
