摘要
目的盐酸托烷司琼片为Ⅳ类新药,为节约开发费用,更好的控制质量,建立了本品血浆含量检测方法。方法建立以LC-MS法测定盐酸托烷司琼血浆含量的方法,色谱柱为HypersilGoldC18柱(150×2.1mm,5μm);流动相为甲醇:水(用醋酸调整pH值为4.8)=52:48;流速为0.2mL·min-1,选用ESI离子源,采用正离子方式、目标二级离子选择反应离子扫描(SRM),扫描时间为0.03s,测定盐酸托烷司琼的含量。结果线性回收方程:Y=0.0131231+0.0328806X,采用1/X2加权,相关系数为0.9924,线性范围:0.2～40ng·mL-1。平均回收率98.55%,RSD<10%。结论此种方法准确、稳定,适用于盐酸托烷司琼的血浆含量测定。
Objective Tropisetron hydrochloride tablets is the fouth new drugs, in order to save de- velopment costs and better quality control, A method for determining tropisetron hydrochloride in plasma by liquid chromatograph-mass spectrometer was developed. Method LC-MS detection with positive model was described, granisetron hydrochloride was used as the intemal standard. After centrifuging, 5μL super- natant was injected into a Cls Shim-pack 150 mm × 2.1mm I.D. column. Mobile phase consisted of methanol and pure water （adjusted to pH 4.8） with a volume ratio of 52：48. The flow rate was of 0.2 mL.min-1. ESI ion source and selective reaction monitoring was used, and the scan time is 0.03s. Results The recovery of the method was more than 90%. The linear range was 0.2-40 ng·mL^-1 （r^2= 0.9924）with a minimum detectable limit of 0.2 ng·mL^-1. The stability analysis showed that plasma sample was stable in different conditions. The average recovery rate is 98.55%, and relative standard deviation is less than 10%. Conclusion The method had a good selectivity and reproducibility and can be used for the investigation of tropisetron hydrochloride in human plasma.
出处
《肿瘤药学》
CAS
2011年第3期223-226,234,共5页
Anti-Tumor Pharmacy
关键词
盐酸托烷司琼:LC-MS法
含量测定
Tropisetron Hydrochloride
Liquid Chromatograph-mass Spectrometer, Plasma
