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Summary

A novel stability-indicating reversed-phase (RP) HPLC method has been developed and validated for quantitative analysis of eplerenone in the bulk drug and in a pharmaceutical dosage form. Use of a 250 mm × 4.6 mm, 5-μm particle, C18 column with 55:45 (v/v) 50 mM ammonium acetate buffer (pH 7)-acetonitrile as isocratic mobile phase enabled separation of the drug from its degradation products. UV detection was performed at 240 nm. The method was validated for linearity, accuracy (recovery), precision, specificity, and robustness. The linearity of the method was excellent over the range 10–100 μg mL−1 (correlation coefficient 0.999). The limits of detection and quantification were 0.019 and 0.053 μg mL−1, respectively. Recovery of eplerenone from the pharmaceutical dosage form ranged from 100.97 to 101.25%. Eplerenone was subjected to stress conditions (hydrolysis (acid, base), oxidation, photolysis, and thermal degradation) and the stressed samples were analysed by use of the method. Degradation was observed in acid, base, and 30% H2O2. The drug was stable under the other stress conditions investigated. The degradation products were well resolved from main peak. The forced degradation studies prove the stability indicating power of the method.

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Summary

This paper includes the development of a novel, systematic, quality by design (QbD)-based high-performance thin-layer chromatography (HPTLC) method for the simultaneous estimation of torsemide and eplerenone. Chromatographic separation was carried out on aluminum-backed silica gel 60 F254 plates using toluene-ethyl acetate-glacial acetic acid (7:3:0.1, V/V) as the mobile phase. UV detection was carried out at 297 nm for torsemide and 247 nm for eplerenone. A 3-factor 17-run regular 3-level factorial design was applied to factor screening studies, and Box–Behnken design was utilized for optimization of the experimental parameters of HPTLC for obtaining anticipated chromatographic conditions. Risk assessment was executed to understand the basic method parameters. From the risk assessment, 3 independent parameters, such as band length, saturation time, and wavelength, were selected and studied for the impact of these 3 parameters on the responses. The method yields compact and well-resolved band at R F = 0.24 ± 0.02 for torsemide and R F = 0.50 ± 0.02 for eplerenone. In the linear regression analysis carried out for torsemide and eplerenone, the regression coefficient was found to be r 2 = 0.999 for torsemide and r 2 =0.995 for eplerenone. The method was validated for validation parameters like accuracy, precision, robustness, limit of detection, and limit of quantification as per the International Conference on Harmonization (ICH) guidelines.

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Pachychorioidealis kórképek

Pachychoroid diseases

Orvosi Hetilap
Authors: Róbert Gergely, Mónika Ecsedy, Illés Kovács, András Papp, Miklós Resch, Zsuzsa Récsán, Antal Szabó, and Zoltán Zsolt Nagy

Összefoglaló. Célunk, hogy közleményünkben összefoglaljuk a pachychorioidealis kórképekkel kapcsolatos ismereteket egy-egy saját esettel illusztrálva. Az irodalmi adatok és a saját klinikai tapasztalatok alapján összegeztük a pachychorioidealis kórképekkel kapcsolatos ismereteinket, az alcsoportok kezelési lehetőségeiről összefoglaló folyamatábrát készítettünk. A pachychorioidealis kórképekbe a következő betegségek tartoznak: centrális serosus chorioretinopathia (CSCR), pachychorioidealis pigmentepitheliopathia (PPE), pachychorioidealis neovasculopathia (PNV), polypoid chorioidealis vasculopathia (PCV), peripapillaris pachychorioidealis syndroma (PPS), focalis chorioideaexcavatio (FCE). A pachychorioidealis kórképek közös jellemzője a chorioidea kvantitatív vagy kvalitatív eltérései, melyekhez gyakran subretinalis folyadékgyülem társul. A betegségcsoportnak jelenleg nincs standard kezelési protokollja; a többféle kezelési mód közül néhány hatékonyabbnak bizonyul, az alcsoportok között azonban lényeges különbségek mutatkoznak. Összegezzük, hogy melyik alcsoportban érdemes eplerenonetablettás kezeléssel, mikropulzuslézer-kezeléssel, verteporfinos fotodinámiás kezeléssel (PDT) vagy intravitrealis anti-VEGF-injekciós kezeléssel kezdeni. Orv Hetil. 2020; 162(20): 770–781.

Summary. The aim of this study is to present our knowledge about pachychoroid diseases using case reports, literature review and our own clinical experiences. A summary flow chart of treatment options for the subgroups was prepared, too. Pachychoroid diseases include the following: central serous chorioretinopathy (CSCR), pachychoroid pigment epitheliopathy (PPE), pachychoroid neovasculopathy (PNV), polypoidal choroidal vasculopathy (PCV), peripapillary pachychoroid syndrome (PPS), focal choroidal excavation (FCE). A common feature of pachychoroid diseases is the quantitative or qualitative abnormality of the choroidea, which is often associated with subretinal fluid accumulation. The disease group does not currently have a standard treatment protocol; some of the multiple treatments prove to be more effective, however, there are significant differences between the subgroups. We summarize which subgroup benefits from eplerenone tablet therapy, micropulse laser therapy, verteporfin photodynamic therapy or intravitreal anti-VEGF injection therapy. Orv Hetil. 2020; 162(20): 770–781.

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the special pharmacologic properties of eplerenone. Int. J. Cardiol., 2015, 200, 3–7. 20 Williams, B., MacDonald, T. M., Morant, S., et al., for the British

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Pitt, B., Remme, W., Zannad, F., et al.: Eplerenone, a selective aldosterone blocker, in patients with left ventricular dysfunction after myocardial infarction. N. Engl. J. Med., 2003, 348 , 1309–1321. Zannad

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