Develpoment and evaluation of validation characteristics of the quantitative determination method for loratadine in the syrup
Keywords:validation, pharmaceutical analysis, spectrophotometry, loratadine, syrup
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.
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