高效液相色谱法测定卡巴他赛注射液的有关物质
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篇名: 高效液相色谱法测定卡巴他赛注射液的有关物质
TITLE:
摘要: 目的:建立测定卡巴他赛注射液中有关物质的方法。方法:采用高效液相色谱法。色谱柱为Agilent Eclipse XDB-C18,流动相为水-乙腈-乙醇(梯度洗脱),流速为1.0 mL/min,柱温为35 ℃,检测波长为230 nm,进样量为20 μL。采用建立的方法测定3批卡巴他赛注射液的有关物质。结果:卡巴他赛检测质量浓度线性范围为0.039~11.60 μg/mL(r=0.999 8,n=7),检测限为2×10-4 μg,定量限为8×10-4 μg;精密度试验和重复性试验的RSD<10.0%(n=6)。3批样品单杂量为0.07%~0.08%,总杂量为0.26%~0.29%。 结论:建立的方法操作简便,结果准确可靠,可用于卡巴他赛注射液的有关物质检查。
ABSTRACT: OBJECTIVE: To establish a method for the determination of related substances in Cabazitaxel injection. METHODS: HPLC method was used. The determination was performed on Agilent Eclipse XDB-C18 column with mobile phase consisted of water-acetonitrile-ethanol (gradient elution) at the flow rate of 1.0 mL/min. The column temperature was 35 ℃, and the detection wavelength was set at 230 nm. The sample size was 20 μL. Established method was used to determine related substances in 3 batches of Cabazitaxel injection. RESULTS: The linear relationship of cabazitaxel were 0.039-11.60 μg/mL (r=0.999 8, n=7). The detection limit was 2×10-4 μg, and quantitation limit was 8×10-4 μg. RSD of precision and reproducibility tests were all lower than 10.0% (n=6). The amount of single impurity in 3 batches of samples ranged 0.07%-0.08%, and total amount of impurities were 0.26%-0.29%. CONCLUSIONS: Established method is simple, accurate and reliable, can be used for the determination of related substances in Cabazitaxel injection.
期刊: 2018年第29卷第9期
作者: 冯菊,任凤英,杨晨,李江红,汪锡佳,陈林,石克金
AUTHORS: FENG Ju,REN Fengying,YANG Chen,LI Jianghong,WANG Xijia,CHEN Lin,SHI Kejin
关键字: 卡巴他赛注射液;高效液相色谱法;有关物质;梯度洗脱
KEYWORDS: Cabazitaxel injection; HPLC; Related substance; Gradient elution
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