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Opracowanie technologii wytwarzania dutasterydu o czystości farmaceutycznej

Dams I., Chodyński M., Ostaszewska A., Krupa M., Lipiec-Abramska E., Kubiszewski M., Szczepek W. J.

Przemysł Chemiczny

2015

T. 94, nr 12

2229-2235

Usprawniono i zoptymalizowano konwencjonalną metodę syntezy dutasterydu. Opracowano nową metodę wydzielania i oczyszczania dutasterydu do czystości farmaceutycznej. Zsyntetyzowano wzorce produktów pośrednich oraz zanieczyszczeń dutasterydu i scharakteryzowano je metodami fizykochemicznymi. Po raz pierwszy dokonano pełnej interpretacji widm 1H i 13C NMR dutasterydu. Opracowano wydajny i powtarzalny proces technologiczny wytwarzania farmaceutycznie czystego dutasterydu, spełniający wymogi dobrej praktyki wytwarzania (GMP) i prawa farmaceutycznego.

A known method for synthesis of dutasteride (R. Davis and al., 2002) was modified and improved by replacing 1,2 eq of SOCl2 with 1,05 eq, use of PhMe as reaction medium and product purifn. by recrystn. from the 1:1 AcOEt/heptane mixt. The new technol. allowed manufacturing the product of pharmaceutical-grade purity (99.31%) with high yield (77,2%). The complete 1H and 13C NMR spectral anal. of dutasteride was carried out.

Determination of trace quantities of dutasteride in water and wastewater by solid phase extraction and high-performance liquid chromatography

Wasilewska A., Madajczyk M., Szymański A., Urbaniak W.

Ars Separatoria Acta

2011

No. 8

39-49

Steroid compounds are a kind of pollutants which are increasingly more frequently found in environmental samples. Due to the ever more increasing level of such pollutants and their biological activity, they are of interest to analysts. Our study involved the development of a simple and fast method for the assay of dutasteride in treated industrial waste water using high-performance liquid chromatography. As the steroid concentration in water is much lower than the limit of detection of the UV detector used, the compound assayed in the test water was pre-concentrated using solid-phase extraction. Our procedure has high accuracy and a precision of 2.6%, and the recovery of the analyte from water is 78.6%. The procedure enables the assay of dutasteride at a level of 2 microg/L in water.

Validated reversed-phase high-performance liquid chromatographic and high-performance thin-layer chromatographic methods for simultaneous analysis of tamsulosin hydrochloride and dutasteride in pharmaceutical dosage forms

Patel D. B, Patel N. J.

Acta Chromatographica

2010

Vol. 22, no. 3

419--431

In this research paper we describe validated high-performance liquid chromatographic (HPLC) and high-performance thin-layer chromatographic (HPTLC) methods for simultaneous analysis of tamsulosin hydrochloride and dutasteride in tablet formulations. HPLC was performed on a C 18 column with 85:15 ( υ/υ ) methanol-0.02 M ammonium acetate buffer (pH 9.5, adjusted with triethylamine) as mobile phase. HPTLC was performed on aluminium foil-backed silica gel G60F 254 layers with toluene-methanol-triethylamine 9:1.5:1 ( υ/υ/υ ) as mobile phase. In HPLC, quantification was achieved by photo diode-array (PDA) detection at 274 nm over the concentration range 1–20 μg mL -1 for both; mean recovery was 98.18 ± 0.698 and 99.94 ± 0.611% for TAM and DUTA, respectively. In HPTLC, quantification was achieved by UV detection at 280 nm over the concentration range 200–2000 ng per band for both; mean recovery was 99.66 ± 0.892 and 100.05 ± 1.012% for TAM and DUTA, respectively. These methods are simple, precise, and sensitive, and are suitable for simultaneous analysis of TAM and DUTA in tablet formulations.