Fernández Marcos, Barcia Emilia, Negro Sofía
Departamento de Farmacia y Tecnología Farmacéutica, Facultad de Farmacia, Universidad Complutense de Madrid, 28040 Madrid, Spain.
J Pharm Biomed Anal. 2009 Jul 12;49(5):1185-91. doi: 10.1016/j.jpba.2009.02.031. Epub 2009 Mar 13.
In the present study, a reverse phase high performance liquid chromatographic method was developed and validated for the determination of rasagiline mesylate in biodegradable microspheres. Chromatographic separation was carried out on a RP-18 column using a mobile phase consisting of acetonitrile:water (5:95, v/v) adjusted at pH 3.1. Flow rate was 1.0 ml min(-1) and UV detection at 290 nm. Acyclovir was used as the internal standard. The calibration curve was linear over the range 0.5-20.0 microg ml(-1). R.S.D. for precision was <1.8%. Accuracy ranged between 99.01% and 102.55% with a R.S.D. lower than 1.3%. LOD and LOQ were 0.07 microg ml(-1) and 0.23 microg ml(-1), respectively. The method was simple, rapid, and easy to apply, making it very suitable for routine analysis of rasagiline mesylate in biodegradable PLGA microspheres. It could be also used with reliability for the determination of the drug in other pharmaceutical dosage forms.
在本研究中，开发并验证了一种反相高效液相色谱法，用于测定可生物降解微球中甲磺酸雷沙吉兰的含量。色谱分离在RP - 18柱上进行，流动相由乙腈:水(5:95, v/v)组成，pH值调至3.1。流速为1.0 ml min(-1)，在290 nm处进行紫外检测。阿昔洛韦用作内标。校准曲线在0.5 - 20.0 μg ml(-1)范围内呈线性。精密度的相对标准偏差(R.S.D.)<1.8%。准确度在99.01%至102.55%之间，R.S.D.低于1.3%。检测限(LOD)和定量限(LOQ)分别为0.07 μg ml(-1)和0.23 μg ml(-1)。该方法简单、快速且易于应用，非常适合对可生物降解的聚乳酸 - 羟基乙酸共聚物(PLGA)微球中甲磺酸雷沙吉兰进行常规分析。它也可可靠地用于测定其他药物剂型中的该药物。
