Development and validation of a reverse phase liquid chromatography method for the quantification of rasagiline mesylate in biodegradable PLGA microspheres.
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.
Fernández
Marcos
M
Departamento de Farmacia y Tecnología Farmacéutica, Facultad de Farmacia, Universidad Complutense de Madrid, 28040 Madrid, Spain. marferna@udec.cl
Barcia
Emilia
E
Negro
Sofía
S
D001673:Biodegradation, Environmental; D002138:Calibration; D002853:Chromatography, Liquid / Q000295:instrumentation / Q000379:methods*; D004355:Drug Stability; D006863:Hydrogen-Ion Concentration; D007189:Indans / Q000032:analysis* / Q000737:chemistry; D019344:Lactic Acid / Q000737:chemistry*; D008863:Microspheres; D015394:Molecular Structure; D008996:Monoamine Oxidase Inhibitors / Q000032:analysis* / Q000737:chemistry; D010602:Pharmacopoeias as Topic; D011100:Polyglycolic Acid / Q000737:chemistry*; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013056:Spectrophotometry, Ultraviolet; D013696:Temperature; D013997:Time Factors
D007189:Indans; D008996:Monoamine Oxidase Inhibitors; C031967:rasagiline; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011100:Polyglycolic Acid; D019344:Lactic Acid