FARMASÖTİK BİR PREPARATTAKİ İKİLİ KARIŞIMIN SPEKTROFOTOMETRİK SİNYAL İŞLEME TEKNİĞİ KULLANILARAK AYNI ANDA MİKTAR TAYİNİ VE VALİDASYONU

Öz

Amaç: Bu çalışmada, tablette irbesartan (IRB) ve hidroklorotiyazidin (HCT) aynı anda miktar tayini için hızlı ve güçlü bir sinyal işleme yaklaşımı, spektrum oranları türev spektrofotometri (RDS) yöntemi geliştirilmiştir. RDS yöntemi, IRB ve HCT'nin UV spektrumlarına uygulanmıştır.

Gereç ve Yöntem: Kalibrasyon denklemleri, sırasıyla IRB tayini için 236.3 nm'de ve HCT tayini için 260.0 nm'de ölçülerek elde edilmiştir. Önerilen yöntem, geri kazanım çalışmaları, gün içi ve günler arası testler ve standart ekleme tekniği kullanılarak doğrulanmıştır.

Sonuç ve Tartışma: Bu çalışma, IRB ve HCT'nin sentetik karışımları ve tabletlerinde aynı anda miktar tayini için hızlı ve güçlü bir sinyal işleme yöntemi uygulamayı amaçlamaktadır. Görülebileceği gibi, iki ilacın UV spektrumları aynı spektral bölgede güçlü bir şekilde örtüşmektedir. Doğrudan geleneksel absorbans ölçümleri, spektral girişim nedeniyle IRB-HCT tablet analizi için beklenen sonuçları vermemektedir. Bununla birlikte, makul bir spektral analiz sonucuna ulaşmak için, esas olarak spektrum oranları türev spektrofotometri işleminin IRB-HCT karışımlarının kantitatif tayinine bir ayırma prosedürüne gerek kalmadan uygulanmasına odaklanılmıştır.

Anahtar Kelimeler

• Kantitatif tayin
• spektrofotometri
• sinyal işleme
• türev
• validasyon

SIMULTANEOUS QUANTITATIVE RESOLUTION AND VALIDATION OF A BINARY MIXTURE IN A PHARMACEUTICAL DOSAGE FORM BY USING A SPECTROPHOTOMETRIC SIGNAL PROCESSING TECHNIQUE

Öz

Objective: In this context, a rapid and powerful signal processing approach, a ratio-derivative spectrophotometry (RDS) method were developed for the simultaneous determination of irbesartan (IRB) and hydrochlorothiazide (HCT) in a tablet.

Material and Method: The RDS method was applied to the UV spectra of the IRB and HCT. The calibration equations were obtained by measuring amplitudes at 236.3 nm for the IRB determination and at 260.0 nm for the HCT determination, respectively. The proposed method was validated by using the recovery studies, intra-day and inter-day assays and standard addition technique.

Result and Discussion: This study aims to apply a rapid and powerful signal processing method to the simultaneous quantification of IRB and HCT in their synthetic mixtures and tablets. As can be seen, the UV spectra of two drugs overlapped strongly in same spectral region. Direct conventional absorbance measurements do not give expected results for the IRB-HCT tablet analysis mainly due to the spectral interference. However, in order to reach a reasonable spectral analysis outcome, we focused mainly on the application of the ratio-derivative spectra treatment to the quantitative resolution of IRB-HCT mixtures without having to a separation procedure.

Anahtar Kelimeler

• Derivative
• quantitative determination
• spectrophotomety
• signal processing
• validation

Kaynakça

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