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EN
The authorities have identified an emerging trend where over-the-counter products, represented as dietary supplements, contain hidden active ingredients that could be harmful. Consumers may unknowingly take products laced with varying quantities of approved prescription drug ingredients, controlled substances, and untested and unstudied pharmaceutically active ingredients. Hidden ingredients are increasingly becoming a problem in products promoted for sexual enhancement, weight loss, or bodybuilding. The tests have revealed the presence of some undesired substances like sildenafil, tadalafil, vardenafil, and their analogues in tainted sexual enhancement products. The content of these substances is usually around the daily curative dose. A simple high-performance liquid chromatography (HPLC) method for simultaneously determination of sildenafil, vardenafil, tadalafil, dapoxetine, yohimbine, and sibutramine was developed and validated. InfinityLab Poroshell 120 EC-C18 (150 '4.6 mm '4 μm particles) was used, as well as a diode-array detector (DAD) at 230 nm, and a gradient flow with 0.030 М ammonium acetate buffer and acetonitrile. The method is linear in the following range: 2.5–37.5 μg/mL for yohimbine, 2.06–30.9 μg/mL for vardenafil, 2.0–30.0 μg/mL for sildenafil, 3.1–46.5 μg/mL for tadalafil, 1.98–29.7 μg/mL for dapoxetine, and 2.2–66.0 μg/mL for sibutramine. The linearity coefficient is R2 = 1 for all substances. Model matrices were spiked, and the analytical recoveries for all substances are in the range 97.5%–99.5%. The method exhibited an upper hand compared with previously reported methods in terms of speed and simplicity. Additionally, the mobile phase (also used as extracting, column washing, and diluting solvent) was composed of only buffer and acetonitrile, which rendered the method much cheaper than others.
EN
Different composite materials have been investigated in bone regeneration but none of them have a significant regeneration in a short time. In this study, the novel scaffold with the osteoinductive characteristic in order to accelerate bone regeneration for 6 weeks. Tadalafil/β-TCP/Collagen (TβC) and β-TCP/Collagen (βC) composite scaffolds were prepared and analyzed by porosity, biodegradability and MTT tests. And then, three bone defects (8 mm diameter, n = 6 group) were produced and filled with TβC, βC scaffolds and the third defect was unfilled as a control. Samples were taken and evaluated by histological, radiological and histomorphometric evaluation at 4 and 6 weeks. In vitro tests showed that both scaffold approximately had the same results in the percentage of porosity and in vitro cytotoxicity. Biodegradability of the βC scaffold was more than TβC scaffold. In vivo test showed bone regeneration was more in TβC scaffold at 6 weeks based on radiological and histopathologic analysis compared with βC scaffold and control groups. Histomorphometric analysis showed that the amount of the bone regeneration was significant in TβC group in comparison βC and control groups (P < 0.05) at 6 weeks. This study highlights the promising application of TβC scaffold with Tadalafil for successful bone regeneration by enhancing osteogenesis.
EN
A novel stability-indicating LC assay method for quantitative determination oftadalafil in bulk drug and pharmaceutical dosage form in the presence of forced-degradation products was developed and validated. An isocratic reversed phase LC method was developed to separate the drug from its degradation products using a Zorbax SB-C18 column and water-acetonitrile mixture as a mobile phase. Detection was carried out at the wavelength of 235 nm. Tadalafil was subjected to stress conditions in order to perform its hydrolytic (acid, base), oxidative, photolytic, and thermal degradation. Degradation oftadalafil was observed in the presence of acid, base, and 30% H2O2. The drug was found to be stable under other stress conditions. The signals of degradation products were well-resolved from the main peak oftadalafil. Percentage recovery oftadalafil in pharmaceutical dosage form ranged from 98.89% to 101.25%. The developed method was validated with respect to linearity, accuracy (recovery), precision, specificity, and robustness. Forced degradation studies proved the stability-indicating power of the method.
PL
Opracowano i zwalidowano nową metodę ilościowego oznaczania tadalafilu za pomocą chromatografii cieczowej, w obecności produktów rozkładu, pozwalającą na ocenę stabilności surowca i formy farmaceutycznej. Zastosowanie kolumny Zorbax SB-C18 i izokratycznej mieszaniny woda —acetonitryl pozwalało na rozdzielenie leku od produktów rozkładu. Detekcję przeprowadzono przy długości fali 235 nm. Tadalafil poddano ekstremalnym warunkom w celu uzyskania hydrolitycznych (kwas, zasada), oksydatywnych. tbtolitycznych i termicznych produktów rozkładu. Rozkład tadalafilu obserowwoano w obecności kwasów, zasad i 30% H,O2. Lek okazał się trwały w pozostałych ekstremalnych warunkach. Sygnały produktów rozkładu były dobrze oddzielone od głównego piku tadalafilu. Odzysk w przypadku badania postaci farmaceutycznej wynosił od 98,89% do 10 l ,25%. Opacowana. metodę zwalidowano w zakresie liniowości, dokładności (odzysku), precyzji, specyficzności i odporności na zmiany warunków otoczenia. Badania rozkładu w warunkach ekstremalnych wykazały przydatność opracowanej metody do oceny stabilności leku.
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