OPTIMIZATION AND VALIDATION OF HPLC METHOD FOR DETERMINATION OF ASSAY OF ARBUTIN IN UVA-URSI PRODUCTS

Pripravki, ki vsebujejo ekstrakt ali učinkovino vednozelenega gornika, se zaradi vsebnosti arbutina, ki ima antiseptično delovanje, pogosto uporabljajo kot uroantiseptiki za samozdravljenje. Za namene zagotavljanja ustrezne kakovosti in pravilnega odmerjanja galenskega izdelka, ki so ga razvili v Javnem zdravstvenem zavodu Mariborskih lekarn Maribor, smo optimirali in validirali HPLC metodo, ki omogoča ugotavljanje vsebnosti arbutina v pripravkih, ki vsebujejo ekstrakt vednozelenega gornika (Arctostaphylos uva-ursi L.). Kromatografske pogoje smo optimirali, da bi dobili najboljšo resolucijo med vrhom arbutina in vrhovi ostalih spojin, ter validirali specifičnost, linearnost, natančnost, delovno območje, meji zaznave in določanja, točnost in robustnost metode. Za Javni zdravstveni zavod Mariborske lekarne Maribor smo izvedli pospešeno stabilnostno študijo, pri čemer smo izdelek shranjevali pri povišani temperaturi in relativni vlažnosti (45 °C in 75 % RH), ter spremljali vsebnost arbutina v pripravku v obdobju enega meseca. Dokazali smo, da je predlagana analizna HPLC metoda za ugotavljanje vsebnosti arbutina primerna, natančna in točna. Ugotovili smo, da je arbutin stabilen in da ne razpada pri povišani temperaturi ter relativni vlažnosti.Preparations, containing extract or drug of bearberry leaf, are due to the presence of arbutin often used as urinary antiseptic in self-medication, because of its antiseptic action. For the purposes of ensuring the appropriate quality and the proper dosage of the galenical product, developed by Public Health Care Institution, Pharmacies of Maribor, we have optimized and validated the HPLC method which allows the identification and quantitative determination of the arbutin content in products containing an extract of bearberry leaf (Arctostaphylos uva-ursi L.). The chromatographic conditions have been optimized to obtain the best resolution between the chromatographic peak of arbutin and peaks of other compounds. The parameters such as specificity, linearity, precision, working range, limit of detection (LOD), limit of quantitation (LOQ), accuracy and robustness of the method have also been validated. The accelerated stability study at the elevated temperature and relative humidity (45 °C and 75 % RH) has been performed for the Public Health Care Institution, Pharmacies of Maribor. The content of arbutin in the product was analyzed and monitored during one month period. The proposed analytical HPLC method for the determination of arbutin content is appropriate, precise and accurate. It was established that arbutin is stable and does not decompose at elevated temperature and relative humidity during predetermined time period