摘要
目的:建立盐酸帕洛诺司琼中3个异构体的分离和含量测定方法。方法:采用以替考拉宁手性柱CHIROBIOTIC TTM(250 mm×4.6 mm,5μm),流动相为甲醇-冰醋酸-三乙胺(100:0.5:0.3),流速:0.5 mL·min-1;检测波长:238 nm。结果:盐酸帕洛诺司琼与3个异构体分离良好,保留适宜;3个异构体在2μg·mL-1至20μg·mL-1范围内,线性良好(r=0.9992～0.9999),进样精密度良好(RSD=0.88%～1.7%,n=5)。结论:方法专属性好、精密度高,适用于盐酸帕洛诺司琼异构体的测定。
Objective：To develop an HPLC method for separation and determination of three optical isomers in palonosetron hydrochloride.Methods：The analysis was carried out on CHIROBIOTIC TT（250 mm×4.6 mm,5 μm） chiral chromatography column with methanol-glacial acetic acid-triethylamine（100：0.5：0.3） as the mobile phase at the flow rate of 0.5 mL·min-1,and the detection wavelength was 238 nm.Results：Good retention and separation for palonosetron hydrochloride and its three optical isomers were achieved.The linear calibration was found for three optical isomers within the range of 2 to 20 μg·mL-1（r=0.9992-0.9999）.The precision was good with RSD of 0.88%-1.7%（n=5）.Conclusion：The developed method is specific and accurate with very good ruggedness and suitable for the determination of palonosetron hydrochloride and its three optical isomers.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2012年第6期978-980,共3页
Chinese Journal of Pharmaceutical Analysis
