RAPID ANALYSIS OF RILPIVIRINE, EMTRICITABINE AND TENOFOVIR ACTIVE INGREDIENTS BY NOVEL HPLC METHOD

Öz

Objective: A novel high-performance liquid chromatography (HPLC) method was developed for the simultaneous determination of Emtricitabine (EMT), Tenofovir (TNF), and Rilpivirine (RLP). Material and Method: The analysis was performed using a Waters XBridge C18 (3.5 µm, 4.6 × 150 mm) column. The mobile phase consisted of methanol and triethylamine buffer (pH 3.15) in a 60:40 (v/v) ratio, with a flow rate of 1.2 ml/min. The developed method was successfully applied to standard mixtures and pharmaceutical tablet formulations containing EMT, TNF, and RLP, without matrix interference. Result and Discussion: The proposed technique exhibited good linearity, with correlation coefficients (R²) of 0.999 for EMT, 0.999 for TNF, and 1.000 for RLP. The calibration ranges were 10.0–600.0 µg/ml for EMT, 2.0–75.0 µg/ml for TNF, and 2.0–75.0 µg/ml for RLP. The method was validated in accordance with ICH guidelines, demonstrating high sensitivity, precision, and accuracy. It was found to be a rapid, economical, and efficient approach for the simultaneous determination of these active pharmaceutical ingredients.

Anahtar Kelimeler

• Emtricitabine
• rilpivirine
• RP-HPLC
• simultaneous determination
• tenofovir

RİLPİVİRİN, EMTRİSİTABİN VE TENOFOVİR AKTİF BİLEŞENLERİNİN YENİ HPLC YÖNTEMİYLE HIZLI ANALİZİ

Öz

Amaç: Emtrisitabin (EMT), Tenofovir (TNF) ve Rilpivirin (RLP) aktif bileşenlerinin eş zamanlı tayini için yeni bir yüksek performanslı sıvı kromatografisi (HPLC) yöntemi geliştirilmiştir. Gereç ve Yöntem: Analizler, Waters XBridge C18 (3.5 µm, 4.6 × 150 mm) kolon kullanılarak gerçekleştirilmiştir. Mobil faz, metanol ve trietilamin tamponunun (pH 3.15) 60:40 (v/v) oranındaki karışımından oluşmuştur. Akış hızı 1.2 ml/dak olarak ayarlanmıştır. Geliştirilen yöntem, EMT, TNF ve RLP içeren standart çözelti karışımları ve farmasötik tablet formlarına başarıyla uygulanmış ve matris girişimi gözlenmemiştir. Sonuç ve Tartışma: Önerilen yöntem mükemmel doğrusallık sergilemiş olup korelasyon katsayıları (R²) EMT için 0.999, TNF için 0.999 ve RLP için 1.000 olarak belirlenmiştir. Kalibrasyon aralıkları EMT için 10.0–600.0 µg/ml, TNF için 2.0–75.0 µg/ml ve RLP için 2.0–75.0 µg/ml olarak bulunmuştur. Yöntem, ICH kılavuzlarına uygun olarak valide edilmiş ve yüksek seçicilik, doğruluk ve kesinlik göstermiştir. EMT, TNF ve RLP'nin eş zamanlı tayini için hızlı, ekonomik ve verimli bir yöntem olduğu tespit edilmiştir.

Anahtar Kelimeler

• Emtrisitabin
• eş zamanlı tayin
• rilpivirin
• RP-HPLC
• tenofovir

Kaynakça

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