Compatibility determination of potassium orotate with spironolactone by high-performance liquid chromatography
Background: Compatibility determination between active pharmaceutical ingredients (APIs) in fixed-dose combinations is an indispensable step in the elaboration. High-performance liquid chromatography provides information on possible interactions between APIs and their related interaction products....
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| Format: | Article |
| Language: | English |
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Scientific Medical Association of Moldova
2020-10-01
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| Series: | The Moldovan Medical Journal |
| Subjects: | |
| Online Access: | http://moldmedjournal.md/wp-content/uploads/2020/09/moldovan-med-j-2020-63-4-mazur-at-al-full-text.pdf |
| _version_ | 1818459232522993664 |
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| author | Ecaterina Mazur Martin Schmid Livia Uncu |
| author_facet | Ecaterina Mazur Martin Schmid Livia Uncu |
| author_sort | Ecaterina Mazur |
| collection | DOAJ |
| description | Background: Compatibility determination between active pharmaceutical ingredients (APIs) in fixed-dose combinations is an indispensable step in the
elaboration. High-performance liquid chromatography provides information on possible interactions between APIs and their related interaction products.
The purpose of the present study was to investigate the compatibility of potassium orotate in combination with spironolactone by a HPLC method.
Material and methods: The detection was carried out using Liquid Chromatograph Agilent 1100 with UV-VIS detector and a RP-18 reversed column
(250*4 mm, 5 μm), mobile phase of acetonitrile: phosphate buffer solution (pH=4.0) with the ratio 1:49 and 1:1, at flow rate 1 and 1.5 mL/min, injection
volume 20 μL; potassium orotate and spironolactone substances were provided by Sigma Aldrich, USA.
Results: Due to the developed method both separation and simultaneous qualitative and quantitative determination of APIs in the mechanical mixture
were carried out. Spironolactone: retention time 6.9 min, concentration 98.1% (±0.21); potassium orotate: retention time 3.06 min, concentration 91.67%
(±0.15). There were just well-separated symmetrical peaks of APIs and no additional peak in the chromatograms.
Conclusions: There is compatibility between APIs. Further studies will be performed by other methods (DSC, FT-IF Spectrometry) to confirm the
obtained result. |
| first_indexed | 2024-12-14T23:11:05Z |
| format | Article |
| id | doaj.art-079bd087d8204f74a6e0615998c3b504 |
| institution | Directory Open Access Journal |
| issn | 2537-6373 2537-6381 |
| language | English |
| last_indexed | 2024-12-14T23:11:05Z |
| publishDate | 2020-10-01 |
| publisher | Scientific Medical Association of Moldova |
| record_format | Article |
| series | The Moldovan Medical Journal |
| spelling | doaj.art-079bd087d8204f74a6e0615998c3b5042022-12-21T22:44:12ZengScientific Medical Association of MoldovaThe Moldovan Medical Journal2537-63732537-63812020-10-01634354210.5281/zenodo.4016810Compatibility determination of potassium orotate with spironolactone by high-performance liquid chromatographyEcaterina Mazur0https://orcid.org/0000-0003-0725-8410Martin Schmid1https://orcid.org/0000-0003-0055-660XLivia Uncu2https://orcid.org/0000-0003-3453-2243Scientific Center of Medicine, Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, the Republic of MoldovaDepartment of Pharmaceutical Chemistry, Institute of Pharmaceutical Sciences, University of Graz, AustriaScientific Center of Medicine, Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, the Republic of MoldovaBackground: Compatibility determination between active pharmaceutical ingredients (APIs) in fixed-dose combinations is an indispensable step in the elaboration. High-performance liquid chromatography provides information on possible interactions between APIs and their related interaction products. The purpose of the present study was to investigate the compatibility of potassium orotate in combination with spironolactone by a HPLC method. Material and methods: The detection was carried out using Liquid Chromatograph Agilent 1100 with UV-VIS detector and a RP-18 reversed column (250*4 mm, 5 μm), mobile phase of acetonitrile: phosphate buffer solution (pH=4.0) with the ratio 1:49 and 1:1, at flow rate 1 and 1.5 mL/min, injection volume 20 μL; potassium orotate and spironolactone substances were provided by Sigma Aldrich, USA. Results: Due to the developed method both separation and simultaneous qualitative and quantitative determination of APIs in the mechanical mixture were carried out. Spironolactone: retention time 6.9 min, concentration 98.1% (±0.21); potassium orotate: retention time 3.06 min, concentration 91.67% (±0.15). There were just well-separated symmetrical peaks of APIs and no additional peak in the chromatograms. Conclusions: There is compatibility between APIs. Further studies will be performed by other methods (DSC, FT-IF Spectrometry) to confirm the obtained result.http://moldmedjournal.md/wp-content/uploads/2020/09/moldovan-med-j-2020-63-4-mazur-at-al-full-text.pdfhplccombinationpotassium orotatespironolactone |
| spellingShingle | Ecaterina Mazur Martin Schmid Livia Uncu Compatibility determination of potassium orotate with spironolactone by high-performance liquid chromatography The Moldovan Medical Journal hplc combination potassium orotate spironolactone |
| title | Compatibility determination of potassium orotate with spironolactone by high-performance liquid chromatography |
| title_full | Compatibility determination of potassium orotate with spironolactone by high-performance liquid chromatography |
| title_fullStr | Compatibility determination of potassium orotate with spironolactone by high-performance liquid chromatography |
| title_full_unstemmed | Compatibility determination of potassium orotate with spironolactone by high-performance liquid chromatography |
| title_short | Compatibility determination of potassium orotate with spironolactone by high-performance liquid chromatography |
| title_sort | compatibility determination of potassium orotate with spironolactone by high performance liquid chromatography |
| topic | hplc combination potassium orotate spironolactone |
| url | http://moldmedjournal.md/wp-content/uploads/2020/09/moldovan-med-j-2020-63-4-mazur-at-al-full-text.pdf |
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