Büşra KANDİLLİ, Afife Büşra UĞUR, Meltem ÇETİN, Fatma DEMİRKAYA MİLOĞLU

A Simple HPLC-UV Method For Simultaneous Determination of Levetiracetam and Carbamazepine

ABSTRACTA combination of levetiracetam (LEV) and carbamazepine (CBZ) may be used toobtain synergistic effect in treatment of epilepsy. The aim of the study is to develop andvalidate a simple reversed phase (RP) HPLC-UV method to determine simultaneouslyLEV and CBZ in pure form and in different pharmaceutical formulations. Separationwas achieved on a C18 column (5 μm, 4.6 mm×250 mm) using a mobile phaseconsisting of methanol and ultrapure water (45:55, v/v) at a flow rate of 1.0 mL/minat 230 nm. Validation parameters (specificity, linearity, accuracy, precision, LOD andLOQ) were studied according to the relevant ICH Guideline. The calibration curveswere linear over a concentration range of 0.5-32 μg/mL for both LEV and CBZ. Theintra- and inter-day accuracy values (as relative error; RE) were less than ±2% and alsothe intra- and inter-day precision values (as the percent relative standard deviation;RSD%) were less than 2%. According to relevant guidelines, the accuracy and precisionof the developed method is suitable. LOD and LOQ values were found to be 0.036 and0.110 μg/mL for LEV and 0.026 and 0.078 μg/mL for CBZ, respectively. The simple,specific, accurate, precise and sensitive analytical method developed could be useful forsimultaneous determination of LEV and CBZ.Keywords: Carbamazepine, HPLC-UV method, Levetiracetam, Validation.ÖZETEpilepsi tedavisinde sinerjik etki elde etmek için levetirasetam (LEV) ve karbamazepin(CBZ) birarada kullanılabilir. Bu çalışmanın amacı, saf halde ve farklı farmasötikformülasyonlarda LEV ve CBZ’yi eş zamanlı olarak belirlemek üzere basit ters faz(RP) HPLC-UV yönteminin geliştirilmesi ve geçerliliğinin gösterilmesidir. Ayırım, C18kolonunda (5 μm, 4.6 mm x 250 mm), metanol ve ultra saf sudan (45:55, h/h) oluşanhareketli faz kullanılarak 1.0 mL/dk akış hızında ve 230 nm’de gerçekleştirilmiştir.Geçerlilik parametreleri (özgüllük, doğrusallık, doğruluk, kesinlik, LOD ve LOQ) ilgiliICH Kılavuzuna göre çalışılmıştır Kalibrasyon eğrileri hem LEV hem de CBZ için0.5-32 μg/mL derişim aralığında doğrusal olarak bulunmuştur. Gün içi ve günler arasıdoğruluk değerlerinin [bağıl hata (BH) olarak] ±%2’den az ve gün içi ve günler arasıkesinlik değerlerinin de [% bağıl standart sapma; %BSS) %2’den az olduğu saptanmıştır.İlgili kılavuzlara göre, geliştirilen yöntemin doğruluğu ve kesinliği uygundur. LOD veLOQ değerleri sırasıyla, LEV için 0.036 ve 0.110 μg/mL ve CBZ için sırasıyla 0.026ve 0.078 μg/mL olarak bulunmuştur. Geliştirilen basit, özgül, doğru, kesin ve hassasanalitik yöntem LEV ve CBZ’nin eş zamanlı olarak saptanması için faydalı olabilir.Anahtar Kelimeler: Geçerlilik, HPLC-UV yöntemi, Karbamazepin, Levetirasetam

Keywords:

Carbamazepine, HPLC-UV method, Levetiracetam, Validation,

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Hacettepe Üniversitesi Eczacılık Fakültesi Dergisi-Cover

Yayın Aralığı: Yılda 4 Sayı
Başlangıç: 1981
Yayıncı: Hacettepe Üniversitesi Eczacılık Fakültesi Dekanlığı

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