HPLC methods for identification and quantification of three active substances In a dermatological preparation ñ viosept ointment
PBN-AR
Instytucja
Narodowy Instytut Leków
Informacje podstawowe
Główny język publikacji
en
Czasopismo
Acta Poloniae Pharmaceutica - Drug Research
ISSN
0001-6837
EISSN
Wydawca
Polskie Towarzystwo Farmaceutyczne
DOI
Rok publikacji
2014
Numer zeszytu
5
Strony od-do
709-719
Numer tomu
71
Identyfikator DOI
Liczba arkuszy
Słowa kluczowe
en
domiphen bromide
tripelennamine hydrochloride
clioquinol
HPLC method
Open access
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Streszczenia
Język
en
Treść
Human body is covered with skin, which pro- vides main protection against external factors. Skin is exposed to mechanical and thermal damage as well as to adverse effects of radiation, chemicals, bacteria, viruses or fungi. These factors can cause a variety of diseases, many of which require long- term and complex treatment. A topical therapy with multi-component extended-spectrum prepara- tions, as the Viosept ointment, typically provides sufficient therapeutic response. The drug contains three active substances: domiphen bromide, tripe- lennamine hydrochloride, and clioquinol. Structural formulas of the substances are shown in Figure 1. Tripelennamine hydrochloride is an antihista- mine and topical anesthetic agent, whereas clio- quinol (quinoline compound) and domiphen bro- mide (quaternary ammonium compound from a group of cationic emulsifiers) have antibacterial and antifungal properties Qualitative requirements and methods of quan- tification for domiphen bromide, tripelennamine hydrochloride, and clioquinol are described in phar- macopoeial monographs. Clioquinol monograph is included in European Pharmacopoeia (Ph. Eur.) and United States Pharmacopoeia (USP). British Pharmacopoeia (BP) contains a monograph for domiphen bromide, and USP features a tripelen- namine hydrochloride monograph. According to USP, purity and assay of clio- quinol substance can be tested using gas chromatog- raphy (GC). USP also provides a detailed descrip- tion of selected pharmaceutical forms containing clioquinol, i.e.: cream, suspension and skin powder containing clioquinol along with zinc oxide, lactic acid and lactose. Clioquinol concentrations in oint- ment and suspension have been determined with gas chromatography after transforming the substance into a silanol derivative, whereas clioquinol concen- tration in skin powder with a spectrophotometric method. An isocratic HPLC method for purity test of clioquinol is described in Ph. Eur. Tripelennamine hydrochloride monograph in USP contains a detailed specification of purity and concentration tests using HPLC method with ion pair chromatography. HPLC has also been used in ANALYSIS HPLC METHOD FOR IDENTIFICATION AND QUANTIFICATION OF THREE ACTIVE SUBSTANCES IN A DERMATOLOGICAL PREPARATION
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PX-56b45b2a8106eb71826df57a