Publication: Pioglitazon hidroklorürün UPLC-UV ile miktar tayini ve validasyonu
Abstract
Amaç: Bu çalışmanın amacı film kaplı tabletlerde bulunan pioglitazon HCl etkenmaddesinin tayini için valide edilmiş ters faz ultra performanslı sıvı kromatografisi(UPLC-UV) yöntemi geliştirmektir.Gereç ve Yöntem: Çalışmamızda pioglitazone HCl etken maddesinin literatürçalışmalarında bulunmayan UPLC cihazında metot geliştirilmesi ve validasyonunsağlanmıştır.Bulgular: Pioglitazon HCl etken maddesinin UPLC cihazında zamandan, kullanılankimyasallardan tasarruf edilerek seçicilik, doğrusallık, doğruluk ve kesinlikparametrelerini karşıladığı ortaya koyulmuştur.Sonuçlar: Geliştirilen yöntem etken maddenin BEH C18 kolonda fosfat tamponu(pH=6):asetonitril (55:45) hareketli fazı ve UV dedektör ile 225 nm dalga boyunda0,4 ml/ dk akış hızında tespitine dayanır. Bu yöntem ticari ilaç formülasyonuanalizinde başarıyla uygulanmıştır.
Objective: The aim of this study is to develop a validated reverse phase ultraperformance liquid chromatography (UPLC-UV) method for determination ofpioglitazone HCl active substance in film coated tablets.Materials and methods: In this study, the method development and validation ofpioglitazone HCl active substance in UPLC device, which is not found in literaturestudies, was achieved.Results: It was demonstrated that the active substance Pioglitazon HCl meets theparameters of selectivity, linearity, accuracy and precision by saving time andchemicals used in UPLC device.Conclusion: The developed method is based on the detection of the active substancein the BEH C18 column with phosphate buffer (pH = 6): acetonitrile (55:45) mobilephase and UV detector at a flow rate of 0.4 ml / min at 225 nm. This method hasbeen successfully applied in commercial drug formulation analysis.
Objective: The aim of this study is to develop a validated reverse phase ultraperformance liquid chromatography (UPLC-UV) method for determination ofpioglitazone HCl active substance in film coated tablets.Materials and methods: In this study, the method development and validation ofpioglitazone HCl active substance in UPLC device, which is not found in literaturestudies, was achieved.Results: It was demonstrated that the active substance Pioglitazon HCl meets theparameters of selectivity, linearity, accuracy and precision by saving time andchemicals used in UPLC device.Conclusion: The developed method is based on the detection of the active substancein the BEH C18 column with phosphate buffer (pH = 6): acetonitrile (55:45) mobilephase and UV detector at a flow rate of 0.4 ml / min at 225 nm. This method hasbeen successfully applied in commercial drug formulation analysis.