Develpoment and evaluation of validation characteristics of the quantitative determination method for loratadine in the syrup

Abstract

The problem of allergic diseases growth is quite urgent in the worldIn recent years the concept of pre-asthma -the state combining a number of pathological signs has been formed. According to the studies they are precoursors of development of the real asthmatic attacks. Among them there are various kinds of allergy (allergic rhinosinusopathy, enteropathy, medicamental dermatitis) and immunological disorders (complement deficiency state, lgE hyperproduction, etc.). In this regard, the medicinal effect on this state is in fact prophylaxis of bronchial asthma.New antihistamine drugs (Н 1 -receptor antagonists) are referred to the medicines that are successfully used in the treatment and prevention of seasonal allergic rhinitis, allergic conjunctivitis. Unlike the medicines for treating allergic manifestations used for a long period of time, new medicines do not provide a sedative action, do not possess antiserotonin, anticholinergic and a-blocking properties; and it allows to use them more widely in a certain patient population [8].Loratadine is one of the representatives of the group of antihistamines of the second generation that block Н 1 -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. Under the effect of antihistamine drugs the histamine toxicity decreases.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]. But, from our point of view, especially when using in industrial manufacture, spectrophotometric method for loratadine determination can be the most suitable and economical.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. Materials and MethodsClaritin syrup, batch 1АNNA59001, manufactured by Schering-Plough Labo NV, Belgium; the substance of loratadine, batch LRD/0909180, manufactured by Vasudna Pharma Chem Limited were used in the research.The following analytical equipment was used: a "Thermo scientific Evolution 60S" spectrophotometer, "AXIS" balances. The measuring glassware of class A, excipients (glycerine, polypropylene glycol, sodium benzoate) and reagents meeting the requirements of the State Pharmacopoeia of Ukraine (SPhU) were used for the work [1][2][3][4][5].

Development of the procedure of quantitative determination of the biological active substances in the extract of a bupleurum aureum in the composition of a combined dosage form

“…Quantitative content of loratadine in the combined dosage form was determined by spectrophotometric method in a 0.1 M hydrochloric acid solution at a wavelength of 278 nm after the previous removal of other active and auxiliary substances of the syrup by an organic layer [9,10].…”

Malassezia Fungal Dermatitis and Rhipicephalus Sanguineus Tick Infestation in Mixed Breed Dogs

“…Loratadine adalah golongan obat antihistamin generasi kedua yang memblokir H1-reseptor. Loratadine tidak memiliki efek sedatif, tidak memiliki antiserotonin, antikolinergik sehingga memungkinkan untuk digunakan secara luas (Glushchenko, 2014). Obat loratadine memiliki efek samping yang relatif sedikit dikarenakan obat ini diabsorbsi pada bagian proksimal (atas) saluran pencernaan (Nayak et al, 2011).…”

Morphological and lectin histochemical characteristics of spleen under the experimental application of H1-histamine receptor blockers.

“…Актуальною проблемою сучасної медицини є ріст кількості алергічних захворювань: до 40% дорослого населення і 10-20% дітей потерпають від різноманітних форм алергії [4]. Внаслідок цього значно зросло застосування у комплексному лікуванні алергій фармакологічних препаратів, спрямованих з одного боку на пригнічення вивільнення гістаміну мастоцитами, а з іншого -на блокаду гістамінових рецепторів клітин-мішеней (зокрема, гладких міоцитів мікроциркуляторного русла та стінок дрібних бронхів) [5,6].…”