BACKGROUND AND PURPOSE We evaluated the concordance of results from two sets of nonclinical cardiovascular safety studies on pitolisant. EXPERIMENTAL APPROACH Nonclinical studies envisaged both in the International Conference on Harmonization (ICH) S7B guideline and Comprehensive in vitro Pro-arrhythmia Assay (CiPA) initiative were undertaken. The CiPA initiative included in vitro ion channel...

A stability-indicating reversed-phase high-performance liquid chromatographic (RP-HPLC) method was developed for the determination of sodium bisulfate (SB), an antioxidant, in injectable dosage form. The chromatographic separation was achieved on a Zorbax CN (250 mm × 4.6 mm, 5 μm) column, with a mobile phase consisting of a buffer mixture of 0.03 M tetrabutylammonium hydrogen sulfate, 0.01 M p...

A novel approach was used to develop and validate a rapid isocratic Reversed Phase-High Performance Liquid Chromatographic method for the simultaneous estimation of Metformin Hydrochloride and Canagliflozin in bulk and pharmaceutical tablet dosage form with forced degradation studies. The separation was performed by using Kromasil C18 column (250mm×4.6 mm, 5mm particle size), Waters Alliance e2...

A stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed for the simultaneous determination of halometasone, fusidic acid, methylparaben, and propylparaben in topical pharmaceutical formulation. The desired chromatographic separation was achieved on an Agilent Zorbax CN (Cyano), 5 μm (250 × 4.6 mm) column using gradient elution at 240 nm detect...

Phase I clinical trials represent the first step in bringing promising new treatments from the laboratory to the clinic. Although the importance of phase I clinical trials is widely recognized, there is currently no consensus among the scientific, medical, and statistical communities on how best to do these studies in humans. With the advent of targeted therapies, it has become evident that we ...

Forced degradation study on doxorubicin (DOX) was carried out under hydrolytic condition in acidic, alkaline and neutral media at varied temperatures, as well as under peroxide, thermal and photolytic conditions in accordance with International Conference on Harmonization (ICH) guidelines Q1(R2). It was found extremely unstable to alkaline hydrolysis even at room temperature, unstable to acid h...

A simple, fast, and efficient RP-HPLC method has been developed and validated for the simultaneous estimation of Levodropropizine, Chloropheniramine, Methylparaben, Propylparaben, and the quantification of Levodropropizine impurities in the Reswas syrup dosage form. A gradient elution method was used for the separation of all the actives and Levodropropizine impurities by using the X-Bridge C18...

Article history: Received on: 30/06/2016 Revised on: 18/07/2016 Accepted on: 01/09/2016 Available online: 28/12/2016 A simple, specific, accurate and stability indicating reversed phase high performance liquid chromatographic method was developed for the simultaneous determination of dutasteride in pharmaceutical formulations and bulk drugs using C-18 column (150 mm × 4.6 mm, 5.0 μm). The mobil...

This paper analyzes the legal framework applicable in Democratic Republic of Congo, Rwanda and Burundi area fighting against illegal natural resources exploitation. The study consists first all analysis international instruments relating to exploitation resources. principle permanent sovereignty States over is recognized law. Other texts governing have also been adopted. But often them do not b...