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Please use this identifier to cite or link to this item: http://hdl.handle.net/20.500.12710/30074
Title: Analysis of spironolactone in compound powder by ultraviolet-visible spectrophotometry
Authors: Mazur, Ecaterina
Keywords: spironolactone;UV-Vis spectrophotometry;validation
Issue Date: 2024
Publisher: Instituţia Publică Universitatea de Stat de Medicină şi Farmacie „Nicolae Testemiţanu” din Republica Moldova
Citation: MAZUR, Ecaterina. Analysis of spironolactone in compound powder by ultraviolet-visible spectrophotometry. In: Revista de Ştiinţe ale Sănătăţii din Moldova = Moldovan Journal of Health Sciences. 2024, vol. 11, nr. 4, pp. 38-43. ISSN 2345-1467. DOI: https://doi.org/10.52645/MJHS.2024.4.06
Abstract: Introduction. Spironolactone (Spir) is a selective and competitive antagonist of aldosterone that increases the excretion of water and sodium while decreasing the excretion of potassium (K+ sparing diuretic). The substance was studied to develop qualitative and quantitative methods of analysis and to validate them according to documents regulating the quality of active pharmaceutical ingredients in the development of pharmaceutical forms. Material and methods. A new dosage form (powder) with Spir was developed and analyzed by a spectrophotometry method using a UV-Vis spectrophotometer (Agilent 8453, USA) with 10.0 mm matched quartz cells at 238±2nm, with methanol as the blank. The method was validated for specificity, linearity, precision, accuracy, robustness, LOD and LOQ. Results. The method was found to be linear in the drug concentration range of 5.0 to 30.0 μg/ml, with a correlation coefficient (R2 ) of 0.9994 for Spir. The LOD of Spir was 0.5 μg/ml and the LOQ was 1.4 μg/ml, indicating the method’s sensitivity. The method was established as accurate (mean recovery values of concentration at 80%, 100%, 120% ranging between 99.9 and 101.7%). Repeatability precision and intermediate precision %RSD values amongst six sample solutions were from 0.13% to 0.25% for Spir (less than 2%). The accuracy (recovery) ranged between 99.9% and 101.7%, with standard deviations ranging from 0.08% to 0.17%. Conclusions. In the presence of common excipients, such as microcrystalline cellulose, lactose monohydrate, and stearic acid, no interferences were observed. This method was found to be suitable for the routine analysis of Spir from the newly developed pharmaceutical form.
metadata.dc.relation.ispartof: Revista de Ştiinţe ale Sănătăţii din Moldova = Moldovan Journal of Health Sciences
URI: https://mjhs.md/sites/default/files/2024-12/MJHS_11_4_2024.pdf
http://repository.usmf.md/handle/20.500.12710/30074
https://doi.org/10.52645/MJHS.2024.4.06
ISSN: 2345-1467
Appears in Collections:Revista de Științe ale Sănătății din Moldova : Moldovan Journal of Health Sciences 2024 Vol. 11, Issue 4

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