期刊
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
卷 49, 期 5, 页码 1185-1191出版社
ELSEVIER
DOI: 10.1016/j.jpba.2009.02.031
关键词
HPLC; Microspheres; PLGA; Validation; Rasagiline mesylate
资金
- Fundacion Mutua Madrilena [AP2696/2008]
- European Union [E06D103774CL]
- Ministry of Education and Universidad de Concepcion, Chile [UCO 0202]
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 mu g 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 mu g ml(-1) and 0.23 mu g ml(-l), 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. (C) 2009 Elsevier B.V. All rights reserved.
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