İbrahim BULDUK, Nurdoğan TOPAL

Bitkilerde ve Farmasötik Materyallerde L-Dopa için Analiz Metodunun Geliştirilmesi ve Validasyonu

L-Dopa antiparkinson ilaçtır ve oral uygulama için kullanılır. Türk habitatlarında yetiştirilen Vicia faba L.’nin yapraklarında,çiçeklerinde ve tohumlarında ve farmasötik dozaj formlarında L-Dopa’ nın belirlenmesi için güvenilir bir sıvı kromatografikmetod geliştirilmiştir. Analizler Ace C18 (5 μm, 4.6 x 250 mm,) kolon kullanılarak yapıldı ve ayırma, 1.2 mL min-1 akış hızında 50mM potassium dihydrogen phosphate (pH 2.3) içeren bir mobil faz kullanılarak 280 nm de UV deedektör ile gerçekleştirildi.Metod, ICH yönergelerinin kabul kriterlerine göre valide edilmiştir. Metod, analiz edilen konsantrasyon aralığında iyidoğrusallık (R2> 0.999), gün içi ve günler arası kesinlik gösterdi. L-Dopa için teşhis limiti (LOD) ve tayin limiti (LOQ) değerleri1.70 ve 5.13 μg mL-1 olarak belirlenmiştir. Geliştirilen metod, ilaç formülasyonlarında ve bitki materyallerinde L-Dopa’ nınbelirlenmesi için başarıyla kullanılmıştır.

Development and Validation of a Quantification Method for L-Dopa inPlants and Pharmaceutical Materials

L-Dopa is an antiparkinsonian drug and is used per oral application. A reliable liquid chromatographic method for determination of L-Dopa in leaves, flowers and seeds of Vicia faba L. grown in Turkish habitats and pharmaceutical dosage forms has been developed. The analysis has been carried out using Ace C18 (5 μm, 4.6 x 250 mm,) column, and the separation was carried out using a mobile phase consisting of 50 mM potassium dihydrogen phosphate (pH 2.3) at a flow rate of 1.2 mL min-1 with UV detection at 280 nm. The method has been validated according to the acceptance criteria of the ICH guidelines. The method demonstrated good linearity (R2 > 0.999) over the assayed concentration range, good intra-day and inter-day precision. The detection limit (LOD) and the quantification limit (LOQ) values were determined as 1.70 and 5.13 μg mL-1 for L-Dopa. Developed method has been successfully used for the determination of L-Dopa in pharmaceutical formulations and plant materials.

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