Abstract
The problem of allergic diseases growth is quite urgent in the world: up to 40% of the adult population and 10-12% of children suffer from this disease. According to the data of epidemiologic studies, the most widespread diseases are bronchial asthma, allergic rhinitis and atopic dermatitis. Among avaliable antihistamine drugs loratadine is one of the most common, it is used for elimination of allergic manifestations both in adults and children. Since for adherence to specifications of the technological process when manufacturing medicines it is necessary to have the developed and validated methods for the quality control, we have proposed a new method for quantitative determination of loratadine in the syrup by the spectrophotometric method. When studying the character of loratadine spectra in alcohol, 0.1 М solution of hydrochloric acid and 0.1 М solution of sodium hydroxide it has been found that the best solvent is 0.1 М solution of hydrochloric acid. The assay was performed by the standard method at the wavelength of 278 nm. The effect of excipients of the syrup was removed by their extraction with ether. The validation characteristics of the method (robustness, accuracy and convergence, linearity, precision) have been determined. The evaluation of such validation characteristics obtained as accuracy (0.18% ≤ 1.54%), convergence (1.6% ≤ 3.2%), intermediate precision (0.62% ≤ 4.80%) allows to control the quality of loratadine in other laboratories according to the method recommended.
Highlights
New antihistamine drugs (Н1-receptor antagonists) are referred to the medicines that are successfully used in the treatment and prevention of seasonal allergic rhinitis, allergic conjunctivitis
When changing the solvent to 0.1 М solution of sodium hydroxide the character of the spectrum does not practically change and the maximum is observed at the wavelength of 246 nm
In case of using 0.1 М solution of hydrochloric acid as a solvent one can observe that the character of the spectrum changes and the maximum is observed at the wavelength of more than 278 nm (Fig. 1)
Summary
New antihistamine drugs (Н1-receptor antagonists) are referred to the medicines that are successfully used in the treatment and prevention of seasonal allergic rhinitis, allergic conjunctivitis. Loratadine is one of the representatives of the group of antihistamines of the second generation that block Н1-receptors. Medicines of this group reduce the body’s response to histamine, eliminate unstriated muscles spasms and prevent development of the tissue edema induced by histamine, reduce the capillary permeability, decrease the hypotensive action of histamine and allergic reactions. The method of liquid chromatography is widely applied for quantitative determination of loratadine both in the pure form and in the combination with other medicinal substance in dosage forms [6, 9,10,11]. The aim of the work is to develop the method for spectrophotometric quantitative determination of loratadine in the syrup for the subsequent application in analysis of medicinal forms
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