Osman MOHAMED, Shaza SHANTİER, Iman ABUREİD, Elrasheed GADKARİEM

Farmasötik Dozaj Formlarında Levodopa ve Karbidopa’nın Eşzamanlı Tayini için bir HPLC yönteminin geliştirilmesi

Çok bileşenli analiz, farmasötik kalite kontrol analizinde büyük bir zorluk teşkil etmiştir. Bu nedenle, mevcut çalışmada, levodopa ve karbidopa'nın toplu ve tablet biçiminde eşzamanlı tayini için seçici, doğru ve kesin bir sıvı kromatografik yöntem (HPLC) geliştirilmiştir. En iyi çözünürlük, mobil faz 1 akış hızında pompalanırken fosfat tamponu pH 2.8 ve asetonitril (95: 5 v/v) karışımı kullanılarak bir C18 kolonunda (5 um partikül boyutu, 250 mm x 4.6 mm ID) elde edildi. ml/dak. Oluşturulan kalibrasyon eğrileri, 1.0'a yakın korelasyon katsayıları ile konsantrasyon aralığında (sırasıyla levodopa ve karbidopa için 25-250 μg/ml ve 2.5 – 25 μg/ml) doğrusaldı. Geliştirilen yöntemin doğruluğu ve kesinliği çok iyiydi (RSD ˂ %2). Önerilen yöntemin geçerliliği, elde edilen verilerin resmi USP yöntemininkilerle istatistiksel olarak karşılaştırılması yoluyla doğrulandı. Geliştirilen yöntemin levodopa ve karbidopanın eş zamanlı analizi için doğru ve geçerli olduğu kanıtlanmıştır.

Anahtar Kelimeler:

Kromatografi, HPLC, Levodopa, Karbidopa, Resmi yöntem, Doğrulama

Development of an HPLC Method for the Simultaneous Determination of Levodopa and Carbidopa in Pharmaceutical Dosage Forms

Multicomponent analysis has presented a great challenge in pharmaceutical quality control analysis. Thus, in the present work, a selective, accurate and precise liquid chromatographic method (HPLC) has been developed for the simultaneous determination of levodopa and carbidopa in bulk and tablet form. The best resolution was achieved on a C18 column (5 µm particle size, 250 mm×4.6 mm I.D.) using a mixture of phosphate buffer pH 2.8 and acetonitrile (95: 5 v/v) as the mobile phase pumped at a flow rate of 1 ml/min. The constructed calibration curves were linear in the concentration range (25˗250 μg/ml and 2.5 – 25 μg/ml for levodopa and carbidopa, respectively) with correlation coefficients close to 1.0. The accuracy and the precision of the developed method were very good (RSD ˂ 2%). The validity of the proposed method was confirmed through the statistical comparison of the obtained data with those of the official USP method. The developed method proved to be accurate and valid for the simultaneous analysis of levodopa and carbidopa.

Keywords:

Chromatography, HPLC, Levodopa, Carbidopa, Official method, Validation,

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