DEVELOPMENT AND VALIDATION OF AN HPLC METHOD FOR THE QUANTIFICATION OF BENZOCAINE AND FUSIDIC ACID SIMULTANEOUSLY IN MICROEMULSION FORMULATION

Yıl 2025, Cilt: 49 Sayı: 3, 659 - 671, 19.09.2025

Muhammet Davut Arpa , Emre Şefik Çağlar , Neslihan Üstündağ Okur

https://doi.org/10.33483/jfpau.1603920

Öz

Objective: The purpose of this study was to develop and validate an analytical technique for quantification in the microemulsion formulation containing fusidic acid and benzocaine developed for the treatment of mild and moderate wounds.
Material and Method: Acetonitrile and acetic acid (0.1%) were used as a mobile phase in the HPLC method. The flow rate and injection volume were determined. The ICH Q2 guideline was followed in the validation of the developed method. Benzocaine (2%) and fusidic acid (2%) were added to the blank microemulsion prepared using ethyl oleate, propylene glycol, ethanol, and Cremophor EL, and the selectivity of the HPLC method for both these substances was investigated.
Result and Discussion: The ratio of acetonitrile to acetic acid (0.1%) was determined to be 70:30 (v/v). The injection volume of 20 µl and the flow rate of 1 ml·min-1 were set. The developed method, which demonstrated a high correlation coefficient (0.9999) and a low variation coefficient (<2%), was simple, inexpensive, convenient, selective, and suitable for the analysis of both substances at the same wavelength (210 nm).

Anahtar Kelimeler

Analytical method , benzocaine , fusidic acid , HPLC , microemulsion

MİKROEMULSİYON FORMÜLASYONUNDA BENZOKAİN VE FUSİDİK ASİT MİKTAR TAYİNİ İÇİN HPLC METODU GELİŞTİRİLMESİ VE VALİDASYONU

Öz

Amaç: Bu çalışmanın amacı, hafif ve orta dereceli yaraların tedavisi için geliştirilen benzokain ve fusidik asit içeren mikroemülsiyon formülasyonunda miktar tayini için analitik yöntem geliştirilmesi ve valide edilmesidir.
Gereç ve Yöntem: HPLC metodunda mobil faz olarak asetonitril ve asetik asit (0.1%) kullanıldı. Akış hızı ve enjeksiyon hacmi belirlendi. Geliştirilen metodun doğrulamasında ICH Q2 kılavuzuna uyulmuştur. Etil oleat, propilen glikol, etanol ve Cremophor EL kullanılarak hazırlanan boş mikroemülsiyona benzokain (%2) ve fusidik asit (%2) ilave edildi ve HPLC metodunun bu iki madde için seçiciliği araştırıldı.
Sonuç ve Tartışma: Asetonitrilin asetik aside (%0.1) oranı 70:30 (h/h) olarak belirlendi. Enjeksiyon hacmi 20 μl ve akış hızı 1 ml·dk-1 olarak ayarlandı. Yüksek korelasyon katsayısı (0.9999) ve düşük varyasyon katsayısı (<%2) gösteren geliştirilen yöntem basit, ucuz, seçici, kullanışlı ve her iki maddenin aynı dalga boyunda (210 nm) analizi için uygundu.

Anahtar Kelimeler

Analitik metot , benzokain , fusidik asit , HPLC , mikroemülsiyon

Kaynakça

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