盐酸帕洛诺司琼3个光学异构体的分离与测定

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。

HPLC separation and determination of three optical isomers of palonosetron hydrochloride

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.