SEÇİCİ SEROTONİN GERİ ALIM İNHİBİTÖRLERİNİN TABLET FORMÜLASYONLARINDA EŞ ZAMANLI TAYİNİ İÇİN RPLC YÖNTEM GELİŞTİRİLMESİ VE VALİDASYONU

Year 2023, , 383 - 393, 20.05.2023

Ebru Çubuk Demiralay , Fatma Ürer , Zehra Üstün , Yaşar Doğan Daldal

https://doi.org/10.33483/jfpau.1199157

Abstract

Amaç: Seçici serotonin geri alım inhibitörleri (SSRI) depresyon tedavisinde en çok kullanılan bileşiklerdir. Bu bileşiklerin kromatografik ayrımları ve kantitatif tayinlerinin belirlenmesi, bileşiklerin klinik kullanımlarında ve yapılan biyofarmasötik çalışmaların başarısında oldukça önemlidir. Bu nedenle bu çalışmada tablet formülasyonunda SSRI'ların kantitatif tayini için kromatografik koşulların Ters faz sıvı kromatografi yöntemi ile optimize edilmesi amaçlanmıştır.
Gereç ve Yöntem: Çalışılan bileşikler için optimum ayırma koşulu, bileşiklerin alıkonma değerleri ile pH ve mobil faz bileşimi arasındaki ilişkiye göre belirlenmiştir. Kromatografik ayrım, hibrit bazlı ve bazik bileşiklerin tayini için yaygın olarak kullanılan X Terra C18 kolonu (250 x 4.6 mm I.D., 5 μm) kullanılarak gerçekleştirilmiştir. Geliştirilen yöntemin validasyonu; doğrusallık, kesinlik ve doğruluk parametrelerine göre yapılmıştır.
Sonuç ve Tartışma: Tablet formülasyonlarındaki etken maddelerin tayini için geliştirilen yöntem başarıyla uygulanmış ve valide edilmiştir. Elde edilen deneysel SSRI miktarları, ticari formülasyonlarda belirtilen miktarlar ile uyumlu olarak bulunmuştur. Hesaplanan geri kazanım yüzdeleri, çalışılan bileşiklerin kantitatif tayini için geliştirilen numune hazırlama tekniklerinin dış etkenlerden etkilenmediğini göstermektedir. Elde edilen sonuçlar değerlendirildiğinde, geliştirilen yöntemin çalışılan bileşiklerin rutin analizlerine uygun olduğu görülmüştür.

Keywords

Antidepresan, kantitatif analiz, metot optimizasyonu, RPLC

RPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS DETERMINATION OF SELECTIVE SEROTONIN REUPTAKE INHIBITORS IN TABLET FORMULATIONS

Abstract

Objective: Selective serotonin reuptake inhibitor (SSRIs) compounds are the most used compounds in the treatment of depression. The determination of chromatographic separation and quantitative determination of these compounds is very important in the clinical use of these compounds and the success of biopharmaceutical studies. For this reason, this study, it was aimed to optimize the chromatographic conditions for the quantitative determination of SSRIs in tablet formulation by Reversed phase liquid chromatography method.
Material and Method: The optimum separation condition for the studied compounds was determined based on the relationship between the retention values of the compounds and the pH and the content of the mobile phase. Chromatographic determination was made on the X Terra C18 column (250 x 4.6 mm I.D., 5 μm), which is widely used for the determination of hybrid-based and basic compounds. The validation of the developed method was carried out based on the parameters of linearity, precision, and accuracy.
Result and Discussion: The developed and validated method was successfully applied for the determination of active ingredients in the tablet dosage form. The experimental results of the amount of studied SSRIs in selected commercial tablets are in good agreement with the label claims. The calculated percent recoveries show that the sample preparation techniques developed for the quantification of the compounds studied are not affected by interferences. The evaluation of the obtained results showed that the developed method is suitable for the routine use of studied compounds.

Keywords

Antidepressant, method optimization, quantitative analysis, RPLC

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