TABLETLERDE GLİKLAZİT MİKTAR TAYİNİ İÇİN SPEKTROFOTOMETRİK YÖNTEM GELİŞTİRME VE DOĞRULAMA

Abstract

Amaç: Dozaj formlarında gliklazid miktar tayini için yeni bir spektrofotometrik yöntem geliştirilmiştir.
Gereç ve Yöntem: Gliklazidin oda sıcaklığında aseton ortamında bromokresol yeşili ile reaksiyona girerek 411 nm'de maksimum absorpsiyona sahip sarı bir ürün oluşturduğu deneysel olarak belirlenmiştir. Kimyasal ajanın optimal konsantrasyonu belirlendi ve araştırılan çözeltilerin stabilitesi, 30 dakika boyunca optik yoğunlukları ölçülerek kontrol edildi ve 62.00 - 94.00 mg/100 ml aralığında Beer yasasına uygun olduğu görüldü. Tespit limiti, reaksiyonun yüksek hassasiyetini gösteren 4.02~10-6 g/ml'dir. Önerilen yöntem, Ukrayna Devlet Farmakopesi gerekliliklerine göre doğrulanmıştır.
Sonuç ve Tartışma: Çalışmanın sonuçları, geliştirilen yöntemin uygulamasının basit ve ekonomik olduğunu ve dozaj formlarının kalite kontrolü için laboratuvarlarda ilaçlarda gliklazidin belirlenmesinde kullanılabileceğini göstermektedir.

Keywords

• Вromokresol yeşili
• gliklazid
• spektrofotometri

SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR GLICLAZIDE QUANTITATION IN TABLETS

Abstract

Objective: A new spectrophotometric method for the gliclazide quantitation in dosage forms has been developed
Material and Method: The subjects of the study were modified-release tablets ("Diaglizide" 80 mg, "Diaglizide MR" 60 mg, "Diaglizide MR" 30 mg, "Diabeton" MR 60 mg, "Gliklada" 60 mg). As a reagent, bromocresol green in acetone was used. Analytical equipment: spectrophotometer Specord 200, electronic scales АВТ-120-5DM.
Result and Discussion: It has been experimentally determined that gliclazide reacts with bromocresol green in acetone medium at room temperature to form a yellow product with maximum absorption at 411 nm. The method was validated for linearity, accuracy, precision, and robustness. The agent’s optimal concentration was established and the stability of the investigated solutions was checked by measuring their optical density for 30 minutes. Subordination of Beer's law is observed in the range of 62.00 - 94.00 mg/100 ml. The limit of detection is 4.02∙10-6 g/ml, which indicates a high sensitivity of the reaction. The proposed method is validated according to the requirements of the State Pharmacopoeia of Ukraine. The results of the study show that the developed method is simple and affordable to implement and can be used to determine gliclazide in drugs in laboratories for quality control of dosage forms.

Keywords

• Вromocresol green
• gliclazide
• spectrophotometry.

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