Bioequivalence study of 2.5 mg film-coated bisoprolol tablets in healthy volunteers.

Background: Bisoprolol is one of the most widely used beta-blockers characterised by cardioselectivity, and it has no intrinsic sympathomimetic activity. It is commonly used in the treatment of coronary heart disease and heart failure.

Aim: The aim of study was to assess the bioequivalence of the film-coated tablets containing 2.

Simplified LC-MS/MS method enabling the determination of azithromycin in human plasma after a low 100mg dose administration.

A sensitive liquid chromatographic-tandem mass spectrometric method was developed and validated to study the pharmacokinetics of a low dose of azithromycin in human plasma. The sample preparation was based on liquid-liquid extraction with the low volume of methyl t-butyl ether. The chromatographic separation was performed on a Symmetry C18 column (50×2.

Bioequivalence study of 500 mg cefuroxime axetil film-coated tablets in healthy volunteers.

The aim of the study was to investigate the bioavailability of a generic product of 500 mg cefuroxime axetil film-coated tablets (test) as compared to that of a branded product (reference) at the same strength to determine bioequivalence and to apply for regulatory approval. The secondary objective of the study was to evaluate tolerability of both products. A double blinded, randomized, crossover, two-period, single-dose, comparative study was conducted in Caucasian healthy volunteers in fasting conditions.

The new HPLC methodology for the chiral separation of tamsulosin enantiomers on amylose tris(3,5-dimethylphenylcarbamate) stationary phase.

New chromatographic method for the enantioseparation of (R,S)-tamsulosin and the determination of (R)- and (S)-tamsulosin was developed with the aid of amylose tris(3,5-dimethylphenylcarbamate) stationary phase. The method was compared to the known procedure for tamsulosin enantioseparation on cellulose tris(3,5-dimethylphenyl carbamate). Careful validation of both methods allowed to prove advantages of the new procedure: significantly better resolution as well as twice better sensitivity.

Bioequivalence and pharmacokinetics of two 10-mg bisoprolol formulations as film-coated tablets in healthy white volunteers: a randomized, crossover, open-label, 2-period, single-dose, fasting study.

Objective: The aim of the study was to investigate the bioavailability of a generic formulation of 10-mg bisoprolol film coated tablets (test) as compared to that of a branded formulation (reference) at the same strength to determine bioequivalence and to apply for regulatory approval. The secondary objective of the study was to evaluate tolerability of both formulations.

Methods: A randomized, crossover, open-label, 2-period, single-dose, comparative study was conducted in healthy white volunteers in fasting conditions.

Development and validation of a sensitive liquid chromatography/tandem mass spectrometry method for the determination of exemestane in human plasma.

Exemestane, irreversible steroidal aromatase inhibitor, acts as a false substrate for aromatase enzyme and significantly lowers circulating estrogen concentrations in postmenopausal women with hormone-sensitive breast cancer. A sensitive bioanalytical method was developed and validated to study pharmacokinetics of exemestane. The method was based on liquid-liquid extraction of exemestane with methyl t-butyl ether followed by reversed-phase liquid chromatography.

An overview of chromatographic methods coupled with mass spectrometric detection for determination of angiotensin-converting enzyme inhibitors in biological material.

Gas and liquid chromatography-mass spectrometry (GC-MS, LC-MS) methods for the determination of angiotensin-converting enzyme inhibitors (ACEIs) and their metabolites in biological material have been reviewed. Since 1980s those hyphenated techniques have been applied to quantitate ACE inhibitors and the dynamic increase in the number of relevant publications can be observed in recent years. Although most of the methods available in the literature were analyses of plasma or serum, assays of blood and urine were also included.

Determination of clopidogrel metabolite (SR26334) in human plasma by LC-MS.

A new, sensitive, specific and reproducible method for determination of clopidogrel metabolite (SR26334) in human plasma has been developed. After liquid-liquid extraction on Chem Elut cartridges with dichloromethane, samples were quantified using reversed-phase high performance liquid chromatography with mass detection. The determination was performed on a Luna C18, 3 microm (75 mmx4.

Determination of new derivatives of genistein in culture media by liquid chromatography.

Methods for determination of genistein and its four new analogues in culture media have been developed to support studies on their potential anticancer activities. The investigated compounds were extracted from the media using liquid-liquid extraction with appropriate solvent. After evaporation of organic solvents each of the dry extracts was reconstituted in appropriate mobile phase.