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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 establish a method for the separation and determination of three isomers of palonosetron hydrochloride. METHODS: The titration was performed on a CHIOBIOTIC TTM (250 mm × 4.6 mm, 5 μm) with a mobile phase of methanol-acetic acid-triethylamine (100: 0.5: 0.3) at a flow rate of 0.5 mL · min -1 Detection wavelength: 238 nm. Results: Palonosetron hydrochloride was well separated from the three isomers and retained properly. The three isomers ranged from 2μg · mL-1 to 20μg · mL-1 with good linearity (r = 0.9992 ~ 0.9999) Injection precision was good (RSD = 0.88% -1.7%, n = 5). Conclusion: The method has good specificity and high precision and is suitable for the determination of palonosetron hydrochloride isomers.