Development and Validation of a HILIC–HPLC Method for the Quantitative Determination of Favipiravir in Tablet Formulations

Abstract

Objective: A validated Hydrophilic Interaction Liquid Chromatography (HILIC) method was developed for the quantitative determination of Favipiravir. Methods: The chromatographic analysis was performed using a high-performance liquid chromatography (HPLC) system comprising a diode array detector, vacuum pump, column thermostat, and autosampler (Agilent 1260, Agilent Technologies, Santa Clara, CA, USA). The analysis was conducted on a ZORBAX RRHD HILIC Plus analytical column (95 Å, 2.1 × 150 mm, 1.8 µm). The mobile phase consisted of acetonitrile and water (80:20, v/v). Chromatographic separation was achieved under isocratic elution at a flow rate of 0.8 mL/min, and Favipiravir was detected at a wavelength of 322 nm. Results: The retention time of Favipiravir was 1.8317 ± 0.002 min, with a limit of detection (LOD) of 0.14 μg/mL and a limit of quantification (LOQ) of 0.47 μg/mL. The regression equation was y = 107.54x + 17.034 with a correlation coefficient (r²) of 0.9997. Conclusion: The proposed method was validated in terms of specificity, linearity, accuracy, precision, LOD, and LOQ, and was successfully applied for the quantitative analysis of Favipiravir in tablet formulations.

Keywords

• Favipiravir
• HILIC
• HPLC

Tablet Formülasyonlarında Favipiravir’in Kantitatif Belirlenmesi İçin HILIC–HPLC Yönteminin Geliştirilmesi ve Validasyonu

Öz

Amaç: Favipiravir’in kantitatif belirlenmesi için valide edilmiş bir Hidrofilik Etkileşimli Sıvı Kromatografi (HILIC) yöntemi geliştirilmiştir. Yöntemler: Kromatografik analiz, diyot dizi dedektörü, vakum pompası, kolon termostatı ve otomatik örnekleyici içeren bir yüksek performanslı sıvı kromatografi (HPLC) sistemi (Agilent 1260, Agilent Technologies, Santa Clara, CA, ABD) kullanılarak gerçekleştirilmiştir. Analiz, ZORBAX RRHD HILIC Plus analitik kolonunda (95 Å, 2.1 × 150 mm, 1.8 µm) yapılmıştır. Mobil faz %80 asetonitril ve %20 sudan (v/v) oluşmuştur. Ayrım, 0.8 mL/dk akış hızında izokratik elüsyonla sağlanmış ve Favipiravir 322 nm dalga boyunda tespit edilmiştir. Bulgular: Favipiravir’in alıkonma süresi 1.8317 ± 0.002 dakika olarak belirlenmiş; tespit limiti (LOD) 0.14 µg/mL ve miktar tayin limiti (LOQ) 0.47 µg/mL olarak hesaplanmıştır. Kalibrasyon eğrisi denklemi y = 107.54x + 17.034 olup korelasyon katsayısı (r²) 0.9997 olarak bulunmuştur. Sonuç: Önerilen yöntem; seçicilik, doğrusallık, doğruluk, kesinlik, LOD ve LOQ açısından valide edilmiş ve Favipiravir’in tablet formülasyonlarında kantitatif analizinde başarıyla uygulanmıştır.

Anahtar Kelimeler

• Favipiravir
• HILIC
• HPLC

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