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    DEVELOPMENT AND VALIDATION OF HPLC ANALYTICAL METHODS USED FOR DETERMINATION OF ASSAY, CONTENT UNIFORMITY AND DISSOLUTION OF IMMEDIATE RELEASE CANDESARTAN CILEXETIL 32 MG TABLETS
    (Polskie Towarzystwo Farmaceutyczne, 2017) Yuce, Meral; Capan, Yilmaz
    New analytical methods have been developed and validated on high performance liquid chromatography (HPLC) to assess the assay, content uniformity and dissolution of immediate release candesartan cilexetil 32 mg tablets. Method development studies were performed on cyano column. Mobile phase of assay and content uniformity test consisted of mixture of 0.05 M phosphate buffer, pH 4.5 and methanol (40 : 60, v/v) adjusted to pH 4.0 with trifluoroacetic acid, whereas mobile phase of dissolution test consisted of mixture of I mM phosphate buffer and acetonitrile (50 : 50, v/v) adjusted to pH 2.0 with tritluoroacetic acid. Mobile phases were pumped at flow rate of 1.0 mL/min, ultraviolet-visible (UV) detector was operated at 254 nm. injection volume was set at 20 mu L. column temperature was held at 25 degrees C. Dissolution medium was 0.05 M phosphate buffer, pH 6.5 including 0.70% (w/v) polysorbate 20. Validation studies met acceptance criteria of system suitability, specificity. linearity and range, accuracy, precision. detection limit (LOD). quantitation limit (LOQ) and robustness parameters.
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    Preformulation of Immediate Release Candesartan Cilexetil Tablets Using Full Factorial Experimental Design
    (Colegio Farmaceuticos Provincia De Buenos Aires, 2016) Yuce, Meral; Guven, Olgun; Karahan, Sevilay; Saracbasi, Osman; Capan, Yilmaz
    This work aimed compatibility and stability studies, five factor and two level (25) full factorial experimental design of immediate release candesartan cilexetil 32 mg tablets. Candesartan cilexetil is a drug substance, which has low solubility and chemical instability properties. Polyethylene glycol (PEG) 4000 showed stability protective property on candesartan cilexetil in tablets. Structural degradation of candesartan cilexetil was prevented by chemical reactions of terminal hydroxyl groups of PEG 4000 with carboxyl, N-H, N=N and anhydride groups of candesartan cilexetil. Stability protective mechanism was realized by converting crystalline candesartan cilexetil to amorphous form inside the amorphous region of PEG 4000. Stability evaluation showed that candesartan cilexetil could be protected ideally by PEG 4000 concentration of 2.5-10 % (w/w) in tablets. Dissolved drug from tablet could be predicted with high capability from statistical model, resulted from experimental design. Thus, stability and dissolution properties of candesartan cilexetil could be controlled in developed tablets.