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 T^TM(250 mm×4.6 mm,5 μm),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2 μg·mL^-1至20 μg·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 T^T(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.

1 Ettinger DS,Bierman PJ,Bradbury B.Antiemesis.J Natl Compr Canc Netw,2007,5:12
2 Navari RM.Palonosetron for the prevention of chemotherapy-induced nausea and vomiting:approval and efficacy.Cancer Manag Res,2009,1∶167
3 JIN Xiang-fei(金祥飞),SHEN Wei-yang(沈卫阳),DANG Zhu(党柱),et al.Recent progress in studies on chromatographic method for analysis of the related impurities in drugs(药物中有关物质的色谱分析研究近况).Progr Pharm Sci(药学进展),2009,33(12):542
4 JIANG Sheng(江生).Correction factor determination of diastereoisomer in palonosetron hydrochloride by HPLC(校正因子法测定盐酸帕洛诺司琼异构体的含量).China Pharm(中国药业),2008,17(17):14
5 YU Xiao-rong(于晓蓉),SONG Min(宋敏),HANG Tai-jun(杭太俊).Direct enantiomeric separation of palonosetron hvdrochloride by chiral HPLC(盐酸帕洛诺司琼光学异构体的手性HPLC检查).Chin New Drugs J(中国新药杂志),2008,17(10):870
6 PAN Hong-juan(潘红娟),WANG Zhe-feng(王哲峰),SHI Hui-lin(时惠麟),et al.Determination of(R,S)-isomer in palonosetron hydrochloride injection by NP-HPLC(盐酸帕洛诺司琼注射液中异构体含量的NP-HPLC测定).Chin J Pharm(中国医药工业杂志),2009,40(8):610
7 Wang M,Ding X,Chen H,et al.Enantioseparation of palonosetron hydrochloride by capillary zone electrophoresis with high-concentration beta-CD as chiral selector.Anal Sci,2009,25(10):1217
8 Tian K,Chen H,Tang J,et al.Enantioseparation of palonosetron hydrochloride by micellar electrokinetic chromatography with sodium cholate as chiral selector.J Chromatogr A,2006,1132(1/2):333
9 SHEN Xiao-xia(沈晓霞),LIU Xiao-dong(刘小东),OUYANG Qiang(欧阳强).RP-ion pair HPLC determination of palonosetron hydrochloride injection and its related substances(反相离子对HPLC法测定盐酸帕洛诺司琼注射液含量及有关物质).Chin J Pharm Anal(药物分析杂志),2008,28(1):72
10 DING Su-ling(丁素玲),YUAN Yu(袁玉).Determination of related substances in palonosetron hydrochloride by RP-HPLC(反相高效液相色谱法检测盐酸帕洛诺司琼的有关物质).China Pharm(中国药业),2010,19(16):25
11 ZHENG Guo-gang(郑国钢).HPLC determination of palonosetron hydrochloride and its related substances(HPLC法测定盐酸帕洛诺司琼的含量及有关物质).Chin J Pharm Anal(药物分析杂志),2010,30(7):1264