DEVELOPMENT AND VALIDATION OF A NEW UHPLC-DAD APPROACH FOR ATOMOXETINE DETECTION IN SEVERAL MEDICINAL PLANTS

Year 2024, Volume: 48 Issue: 1, 189 - 196, 20.01.2024

Burhan Ceylan

https://doi.org/10.33483/jfpau.1345130

Abstract

Objective: Atomoxetine (ATX) is a medication that is extensively used to treat attention deficit hyperactivity disorder in children, adolescents, and adults. The goal of this work was to create a speedy, easy, and sensitive ultra high performance liquid chromatographic method (UHPLC) for the measurement of atomoxetine in various medicinal plants. (Salvia officinalis L., Rosmarinus officinalis L., Melissa officinalis L., Ginkgo biloba L.).
Material and Method: Prior to chromatographic separation, liquid-liquid extraction was applied, which is currently the preferred extraction technique due to its simple, fast and efficient procedure for sample preparation. The chromatographic separation was achieved by reversed phase C18 (5 μm × 4.6 mm × 150 mm) analytical column and a mobile phase consisting of monobasic potassium dihydrogen orthophosphate (pH=6.8) and acetonitrile (50:50 v/v) at flow rate of 0.8 ml/min and diode array detector (DAD) detecting at 215±2 nm.
Result and Discussion: The envisioned method's linear behavior was tested in the 0.5-20 μg/ml range (r2=0.09990). In compliance with International Conference on Harmonisation (ICH) criteria, the method received validation by means of accuracy, precision, repeatability, specificity, robustness, and detection and quantification boundaries. LOD and LOQ values were determined as 0.16 and 0.5 μg/ml. RSD values for hourly and daily measurements are found to be below 2.5% for both assays. The proposed method can be used effectively for quantification of atomoxetine in medicinal and aromatic plants. The proposed analytical procedure represents an efficient method for the quantification and routinee analysis of atomoxetine in medicinal and aromatic plants.

Keywords

Atomoxetine, attention deficit hyperactivity disorder, diode array detector (DAD), medicinal plants, ultra high performance liquid chromatography (UHPLC)

BAZI TIBBİ BİTKİLERDE ATOMOKSETİN TAYİNİ İÇİN YENİ BİR UHPLC-DAD YÖNTEMİNİN GELİŞTİRİLMESİ VE VALİDASYONU

Abstract

Amaç: Atomoksetin (ATX) çocuklarda, ergenlerde ve yetişkinlerde dikkat eksikliği hiperaktivite bozukluğunun tedavisinde yaygın olarak kullanılmaktadır. Bu çalışmada, bazı tıbbi bitkilerde (Salvia officinalis L., Rosmarinus officinalis L., Melissa officinalis L., Ginkgo biloba L.) atomoksetin analizi için hızlı, basit ve hassas bir ultra yüksek performanslı sıvı kromatografik yöntem (UHPLC) geliştirilmesi amaçlanmıştır.
Gereç ve Yöntem: Kromatografik ayırmadan önce, numune hazırlama için basit, hızlı ve verimli prosedürü nedeniyle günümüzde tercih edilen ekstraksiyon tekniği olan sıvı-sıvı ekstraksiyonu uygulanmıştır. Kromatografik ayırma, ters fazlı C18 (5 μm × 4.6 mm × 150 mm) analitik kolon ve monobazik potasyum dihidrojen ortofosfat (pH=6.8) ve asetonitrilden (50:50 h/h) oluşan bir mobil fazda 0.8 ml/dk akış hızında ve 215±2 nm’de diyot dizisi dedektörü (DAD) tespiti ile sağlandı.
Sonuç ve Tartışma: Önerilen yöntemin doğrusallığı 0.5-20 μg/ml (r2=0.9990) aralığında incelenmiştir. Yöntem, Uluslararası Uyumlaştırma Konferansı (ICH) yönergelerine uygun olarak doğruluk, kesinlik, tekrarlanabilirlik, özgüllük, sağlamlık ve dedeksiyon ve kantitasyon limitleri açısından doğrulanmıştır. LOD ve LOQ sırasıyla 0.16 ve 0.5 μg/ml olarak bulundu. Gün içi ve günler arası RSD değerleri her iki test için de %2.5’in altındadır. Önerilen yöntem, tıbbi ve aromatik bitkilerde atomoksetin miktarının belirlenmesi için etkin bir şekilde kullanılabilir. Önerilen analitik prosedür, tıbbi ve aromatik bitkilerde atomoksetinin miktarının belirlenmesi ve rutin analizi için etkili bir yöntemi temsil eder.

Keywords

Atomoksetin, dikkat eksikliği hiperaktivite bozukluğu, diyot dizisi dedektörü (DAD), tıbbi bitkiler, ultra yüksek performanslı sıvı kromatografisi (UHPLC)

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