Ewelina Cebulska, Katarzyna Malik, Kamila Czarnecka, Paweł Szymański
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引用次数: 0
Abstract
WHO has identified the increase in myopia as the world's greatest threat to vision health due to its association with vision-threatening complications like myopic macular degeneration, retinal detachment, cataract and open angle glaucoma. Pharmacological treatment with atropine is assessed as one of the best option in op-tical approaches to the control and inhibit of myopia progression. The aim of this study was to develop analytical method for quality control of 0.1 mg/mL atropine ophthalmic solution. UPLC analytical method for simultaneous determination of atropine sulfate monohydrate and its related substances described in Eur. Ph. and for additional impurities was developed. For method development low-dose of atropine formulations with a wide range of pH 4.5-6.6 were tested and the impact of formulation pH on the impurity profile was noted. The ionized form of tropic acid was observed in our studies in all buffered formulations with pH above 5. Additionally two isomers of atropine N-oxide were observed in the tested preparation with pH 6.6 in the presence of an oxidizing agent and were just possible to integrate with our new developed UPLC method. The ionized form of tropic acid was already defined in Berton et al. publication (1) and observed in the buffered formulation with pH 6.0. Our result complement and extend the impurity profile of atropine in wider pH range of atropine ophthalmic solutions.
期刊介绍:
The international journal of the Polish Pharmaceutical Society is published in 6 issues a year. The journal offers Open Access publication of original research papers, short communications and reviews written in English, in all areas of pharmaceutical sciences. The following areas of pharmaceutical sciences are covered: Analysis, Biopharmacy, Drug Biochemistry, Drug Synthesis, Natural Drugs, Pharmaceutical Technology, Pharmacology and General.
A bimonthly appearing in English since 1994, which continues “Acta Poloniae Pharmaceutica”, whose first issue appeared in December 1937. The war halted the activity of the journal’s creators. Issuance of “Acta Poloniae Pharmaceutica” was resumed in 1947. From 1947 the journal appeared irregularly, initially as a quarterly, then a bimonthly. In the years 1963 – 1973 alongside the Polish version appeared the English edition of the journal. Starting from 1974 only works in English are published in the journal. Since 1995 the journal has been appearing very regularly in two-month intervals (six books a year). The journal publishes original works from all fields of pharmacy, summaries of postdoctoral dissertations and laboratory notes.