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EN
Cefoselis sulphate is a new parenteral cephalosporin, which was launched into therapy in Japan on 9 September, 1998. Cefoselis, like all the other beta-lactams, exhibits its bactericidal eff ects by binding to penicillinbinding proteins. It has a spectrum of activity that covers aerobic and anaerobic gram-positive and gram-negative bacteria. Cefoselis has been approved to treat infections caused by Staphylococcus and Pseudomonas especially respiratory and urinary tract infections. The recommended dose of cefoselis is 1 g twice a day as an intravenous infusion. The duration of therapy is from 5 to 14 days.
PL
Siarczan cefoseliny jest nową cefalosporyną do podawania parenteralnego, wprowadzoną do lecznictwa w Japonii 9 sierpnia 1998 r. Cefoselina, jak inne betalaktamy, działa przeciwbakteryjnie przez łączenie się z białkami wiążącymi penicylinę. Wykazuje spektrum działania wobec bakterii tlenowych i beztlenowych Gram-dodatnich oraz Gram-ujemnych. Wskazana jest w leczeniu infekcji wywołanych przez Staphylococcus i Pseudomonas, a zwłaszcza w zakażeniach dróg oddechowych i moczowych. Zalecane dawkowanie cefoseliny to 1 g dwa razy dziennie w postaci wlewu dożylnego. Czas trwania terapii 5–14 dni.
EN
A first-derivative UV spectrophotometric method, with or without the subtraction technique, was developed for the determination of biapenem in pharmaceutical dosage form in the presence of its degradation products. The method was based on the measurement of first-derivative amplitudes at zero crossing point (λ = 312 nm) and the peak-to-zero technique and validated with regard to linearity, limits of detection and quantitation, selectivity and precision. The observed rate constants for the degradation of biapenem were comparable to those obtained in the stability-indicating HPLC method. [...]
EN
The stability-indicating LC assay method was developed and validated for quantitative determination of cefoselis sulphate in the presence of degradation products formed during the forced degradation studies. An isocratic, RP-HPLC method was developed with C-18 (250 × 4.6 mm, 5 µm) column and 12 mM ammonium acetate-acetonitrile (95:5 V/V) as a mobile phase. The flow rate of the mobile phase was 1.0 mL min−1. Detection wavelength was 260 nm and temperature was 30°C. Cefoselis similarly to other cephalosporins was subjected to stress conditions of degradation in aqueous solutions including hydrolysis, oxidation, photolysis and thermal degradation. The developed method was validated with regard to linearity, accuracy, precision, selectivity and robustness. The method was applied successfully for identification and determination of cefoselis sulphate in pharmaceuticals and during kinetic studies.
EN
Perindopril (PER) belongs to the group of the angiotensin converting enzyme inhibitors and is widely prescribed antihypertensive drug. It can be used in monotherapy or in combination therapy for example with hydrochlorothiazide (HTH). As on the market there is no pharmaceutical formulation containing both drugs and in literature has not been reported any work about effect of HTH on PER degradation process, the primary objective of this study was the assessment of stability of two salts of perindopril - tert-butylamine (PERt) and arginine (PERa) in a mixtures model with HTH in different relative humidities and constant temperature. Objective of the study was establishing the mechanisms of drug decomposition in the presence of HTH. Results were achieved using the high performance liquid chromatography (RP-HPLC). The degradation rate constants for mixtures and pure substances were calculated. Decomposition products have been analyzed by ESI LC/MS and the decomposition mechanism for each salt has been proposed. The degradation of PERt in the presence of HTH took place according to autocatalytic reaction kinetic mechanism, described mathematically by Prout-Tompkins equation, and the decomposition process leads to hydrolysis. HTH in the model mixture with PERa generates a first-order kinetic model of the decomposition reaction, and there are two main products of decomposition: product of hydrolysis and diketopiperazine. Our study showed that HTH has statistically significant positive impact on both salts. It can be suggested that PERt or PERa and HTH can be formulated together, hence there is no negative interaction between the drugs.
EN
The influence of ionising radiation on physicochemical properties of betamipron in solid state was studied. No changes for betamipron irradiated with a dose of 25 kGy, required to attain sterility, was observed by spectroscopic and chromatographic methods. Solid betamipron has proven to be very stable on irradiation, and irradiation has been found to be a suitable method for its sterilization.
EN
Paracetamol (acetaminophen), a pain-killer with antipyretic properties, shows structural polymorphism. It occurs in three polymorphic forms: monoclinic, orthorhombic, and unstable form III. In the study, the commercially available samples of paracetamol (P1 and P2) were examined using X-ray powder diffraction, infrared, and Raman spectroscopy. Results demonstrated that all of the methods defined polymorphic forms of paracetamol in the samples. However, only Raman spectroscopy and PXRD methods detected impurities in the sample P1. These methods transpired to be more sensitive than the FT-IR method, which identified samples of paracetamol as one structural form (monoclinic polymorph). Moreover, the Raman spectroscopy identified impurities in the form P1 as changes in the crystalline form.
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