SIMPLE AND SENSITIVE SPECTROPHOTOMETRIC ASSAYS FOR THE DETERMINATION OF TERBINAFINE HCL ANTIFUNGAL DRUG IN PHARMACEUTICALS

Yıl 2024, Cilt: 48 Sayı: 3, 876 - 889, 10.09.2024

Nagib Qarah , Ezzouhra El-maaıden Kanakapura Basavaiah

https://doi.org/10.33483/jfpau.1348367

Öz

Objective: Two highly sensitive, accurate, inexpensive, and simple spectrophotometric assays were developed and validated for the determination of an anti-fungal drug, Terbinafine HCl (TBH), in pure drug and tablets using potassium permanganate (PP) and disodium 2-(1,3-dioxo-2,3-dihydro-1H-inden-2-yl)quinoline-6,8-disulfonate (DSOQ).
Material and Method: In the present study, Sebifin and Terbiforce 250 mg tablets were used as pharmaceuticals, potassium permanganate KMnO4 and disodium 2-(1,3-dioxo-2,3-dihydro-1H-inden-2-yl)quinoline-6,8-disulfonate in water were used as reagents, and DR 3900 spectrophotometer equipped with 1cm matched quartz cells was used for absorbance measurements.
Result and Discussion: The amount of terbinafine hydrochloride reacting with permanganate and disodium 2-(1,3-dioxo-2,3-dihydro-1H-inden-2-yl)quinoline-6,8-disulfonate in an acidic medium has been determined. The colored reaction products in both cases were measured at the maximum absorptions of 540 nm and 440 nm, respectively. The absorbance measured in each assay as a function of TBH concentration was related to TBH concentrations. Different experimental and variable conditions of assays were done carefully, accurately studied, and optimized. The validation of two assays also was done by following the current guidelines of the International Conference on Harmonization (ICH). Beer’s law for the two methods is obeyed over the concentration ranges 1-15 µg/ml (Correlation coefficient = 0.9983) and 1-18 µg/ml (Correlation coefficient = 0.9989) for methods PP and DSOQ, respectively. Molar absorptivity, limits of detection, and quantification (LOD & LOQ) values were (1.38×104 l/ mol cm, 0.92 & 2.78 µg/ml) for PP assay, and (1.73×104 l/ mol cm, 0.09 & 0.27 µg/ml) for DSOQ assay, respectively. The two assays were successfully applied for the determination of TBH in commercial tablets with reliable and satisfactory results, and hence the proposed assays can be applied in pharmaceutical laboratories of quality control.

Anahtar Kelimeler

Ion-pair, KMnO4, spectrophotometry, terbinafine HCl

FARMASÖTİKLERDE TERBİNAFİN HCL ANTİFUNGAL ETKEN MADDESİNİN BELİRLENMESİ İÇİN BASİT VE HASSAS SPEKTROFOTOMETRİK TAYİNLER

Öz

Amaç: Bir anti-fungal ilaç olan Terbinafin HCl'nin (TBH) saf ilaç ve tabletlerde potasyum permanganat (PP) ve disodyum 2-(1,3-diokso-2,3-dihidro-1H-inden-2-il)kinolin-6,8-izülfonat (DSOQ) kullanılarak tayini için oldukça hassas, doğru, ucuz ve basit iki spektrofotometrik test geliştirilmiş ve valide edilmiştir.
Gereç ve Yöntem: Bu çalışmada, ilaç olarak Sebifin ve Terbiforce 250 mg tabletler, reaktif olarak potasyum permanganat KMnO4 ve disodyum 2-(1,3-diokso-2,3-dihidro-1H-inden-2-il)kinolin-6,8- izülfonat ve absorbans ölçümleri için 1 cm eşleştirilmiş kuvars hücrelerle donatılmış DR 3900 spektrofotometre kullanılmıştır.
Sonuç ve Tartışma: Asidik bir ortamda permanganat ve disodyum 2-(1,3-diokso-2,3-dihidro-1H-inden-2-il)kinolin-6,8-disülfonat ile reaksiyona giren terbinafin hidroklorür miktarı belirlenmiştir. Her iki durumda da renkli reaksiyon ürünleri sırasıyla 540 nm ve 440 nm maksimum absorpsiyonlarında ölçülmüştür. TBH konsantrasyonunun bir fonksiyonu olarak her bir deneyde ölçülen absorbans TBH konsantrasyonları ile ilişkilendirilmiştir. Deneylerin farklı deneysel ve değişken koşulları dikkatlice yapıldı, doğru bir şekilde incelendi ve optimize edildi. İki tahlilin validasyonu da Uluslararası Uyumlaştırma Konferansı'nın (ICH) güncel kılavuzları takip edilerek yapılmıştır. İki yöntem için Beer yasasına, PP ve DSOQ yöntemleri için sırasıyla 1-15 µg/ml (Korelasyon katsayısı = 0,9983) ve 1-18 µg/ml (Korelasyon katsayısı = 0,9989) konsantrasyon aralıklarında uyulmuştur. Molar absorptivite, tespit ve miktar belirleme sınırları (LOD ve LOQ) değerleri PP testi için sırasıyla (1,38×104 l/mol cm, 0,92 ve 2,78 µg/ml) ve DSOQ testi için (1,73×104 l/mol cm, 0,09 ve 0,27 µg/ml) idi. Bu iki analiz, ticari tabletlerde TBH tayini için güvenilir ve tatmin edici sonuçlarla başarıyla uygulanmıştır ve bu nedenle önerilen analizler kalite kontrol farmasötik laboratuvarlarında uygulanabilir.

Anahtar Kelimeler

İyon çifti, KMnO4, spektrofotometri, terbinafin HCI

Kaynakça

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