21-07-2012, 03:53 PM
DEVELOPMENT AND VALIDATION FOR ASSAY AND DISSOLUTION OF CETRAZINE HYDROCHLORIDE
CETRAZINE HYDROCHLORIDE.docx (Size: 180.73 KB / Downloads: 132)
ABSTRACT
Cetirizine is more effective than on demand treatment. Continuous treatment reduces clinical and inflammatory variables more than symptomatic treatment and the on demand therapy can determine acceptable clinical control, but does not reduce allergic inflammation. Cetirizine potently reduced skin responses in immediate allergic reactions without inhibition of early mediators. Citrazine (hcl) is antihistaminic agent. Histamine mediates allergic and inflammatory reactions.Citrazine is being carried out in analytical development as basic principle and application of uv-visible spectrophotometric method .the antihistaminic activity of cetirizine has been clearly documented in a variety of animal and human models.Development and validation of a hplc method for the determination of cetirizine in pharmaceutical dosage forms. A rapid, simple and accurate hplc method is described for the assay of cetirizine in commercial dosage forms. The scope of developing and validating analytical methods is to ensure suitable methods for a particular analyte of more specific, accurate and precise. The main objective for this is to improve the conditions and parameters, which should be followed in the development and validation.
INTRODUCTION
The field of pharmaceutical analysis includes a wide range of analytes, varying in structure from very simple compounds to complex bio molecules. As such, a host of approaches have been and continue to be used in developing reliable analytical methodology for these analytes . In the broadest sense, there are two types of procedures: those that are designed as simple, reliable means of monitoring formulated products in terms of their identity, strength and quality and those that are used during the drug discovery and development stages to answer numerous and fundamentally more challenging questions related to safety, therapeutic effectiveness, drug stability and purity, as well as in helping to develop better understanding of the bio mechanisms and kinetics.
Basic Principle and Application of UV-Visible Spectrophotometric
Spectrophotometric Methods
Spectrophotometry is generally preferred especially by small-scale industries as the cost of the equipment is less and the maintenance problems are minimal. The method of analysis is based on measuring the absorption of a monochromatic light by colorless compounds in the near ultraviolet path of spectrum (200-400nm). The photometric methods of analysis are based on the Beer-Lambert’s law, which establishes that absorbance of a solution is directly proportional to the concentration of the analyte and inversely proportional to its path length. The fundamental principle of operation of spectrophotometer covering UV region consists in that light of definite interval of wavelength passes through a cell with solvent and falls on to the photoelectric cell that transforms the radiant energy into electrical energy measured by a galvanometer.
Mechanism of Action:
Cetirizine, a human metabolite of hydroxyzine, is an antihistamine; its principal effects are mediated via selective inhibition of peripheral H1 receptors. The antihistaminic activity of cetirizine has been clearly documented in a variety of animal and human models. In vivo and ex vivo animal models have shown negligible anticholinergic and antiserotonergic activity. In clinical studies, however, dry mouth was more common with cetirizine than with placebo. In vitro receptor binding studies have shown no measurable affinity for other than H1 receptors.
Pharmacological and clinical properties of cetirizine hydrochloride
A number of reports have characterized cetirizine as a potent histamine H1-receptor antagonist possessing inhibitory effects on eosinophil chemotaxis. In clinical pharmacological tests, cetirizine markedly reduced wheal and flare responses induced by histamines. The inhibition was fast onset, potent and long-lasting. A single clinical dose of cetirizine was more potent in inhibiting wheal response than other antihistamines such as terfenadine, loratadine, epinastine and ebastine. Cetirizine also inhibited eosinophil chemotaxis in vitro at a concentration easily attained after a clinical dose of 10 mg. Eosinophil infiltration into a site challenged with allergen in vivo was also inhibited. Potent antihistaminic effects of cetirizine afforded fast and strong relief from histamine-induced symptoms such as sneezing and rhinorrhoea in allergic rhinitis and itchy sensation in idiopathic chronic urticaria. Inhibitory effect of cetirizine on eosinophil chemotaxis may alleviate minimal persistent inflammation due to faintly but repeated intake of allergen. Such anti-inflammatory properties of cetirizine may be beneficial in reducing hypersensitivity to normalize the upper respiratory tract and eosinophil-related skin inflammation.