The sodium 5-butyl-1,2-diphenyl-6-oxo-1,6-dihydropyrimidine-4-olate quantitative content determination in a standard sample
Introduction. The standard samples (SS) use is a necessary condition for the medicines' quality control implementation. Their development is an urgent problem for the pharmaceutical industry, especially for new biologically active compounds that can be further used as pharmaceuticals.Aim. This...
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| Format: | Article |
| Language: | Russian |
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LLC Center of Pharmaceutical Analytics (LLC «CPHA»)
2021-12-01
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| Series: | Разработка и регистрация лекарственных средств |
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| Online Access: | https://www.pharmjournal.ru/jour/article/view/1109 |
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| author | E. V. Kuvaeva D. A. Kolesnik P. O. Levshukova I. I. Terninko I. P. Yakovlev E. V. Fedorova |
| author_facet | E. V. Kuvaeva D. A. Kolesnik P. O. Levshukova I. I. Terninko I. P. Yakovlev E. V. Fedorova |
| author_sort | E. V. Kuvaeva |
| collection | DOAJ |
| description | Introduction. The standard samples (SS) use is a necessary condition for the medicines' quality control implementation. Their development is an urgent problem for the pharmaceutical industry, especially for new biologically active compounds that can be further used as pharmaceuticals.Aim. This work aim is to establish the 5-butyl-1,2-diphenyl-6-oxo-1,6-dihydro pyrimidone-4-olate sodium quantitative content, for which anti-inflammatory and analgesic activity was previously proven, in a standard sample.Materials and methods. This work aim is to establish the 5-butyl-1,2-diphenyl-6-oxo-1,6-dihydro pyrimidone-4-olate sodium quantitative content, for which anti-inflammatory and analgesic activity was previously proven, in a standard sample. The main method for establishing a substance quantitative content in the SS is the material balance method. The water determination was carried out according to K. Fisher's method (semimicro method). Sulphated ash was determined according to the XIV edition Russian Federation State Pharmacopoeia General Pharmacopoeia Monograph "Sulphated ash". Related impurities and their content were assessed using the HPLC method on a Flexar liquid chromatograph equipped with a diode array detector (Perkin Elmer, USA). The residual solvents' determination was carried out by the headspace method using a gas chromatograph GC-2010Plus Shimadzu with a flame ionization detector. As an additional method for establishing the main component quantitative content, acidimetric titration with the equivalence point potentiometric indication was carried out.Results and discussion. The percentage was determined for the following indicators: water, residual organic solvents, related impurities, sulphated ash. Using the material balance method, it was found that the 5-butyl-1,2-diphenyl-6-oxo-1,6-dihydropyrimidin-4-olate sodium percentage in a standard sample is 96.01 ± 0.50 %. It was found by acidimetric titration that the 5-butyl-1,2-diphenyl-6-oxo 1,6-dihydropyrimidin- 4-olate sodium quantitative content in SS is 95.12 ± 0.02 %. The difference in the certified value can be explained by the fact that during titration, the SS aciform is released, which precipitates in an aqueous medium and contributes to a shift in the equilibrium and pH value. Consequently, the equivalence point is reached somewhat earlier. However, the data are practically comparable, but it is necessary to use the value obtained by the material balance method.Conclusion. A standard sample certification parameters were determined: water content, residual organic solvents, sulphated ash, related impurities. The main component quantitative content was determined using the material balance method and titrimetry (acidimetry with the equivalence point potentiometric indication). |
| first_indexed | 2024-04-10T01:38:48Z |
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| id | doaj.art-1ed493a72acf487d8581a573be02eb08 |
| institution | Directory Open Access Journal |
| issn | 2305-2066 2658-5049 |
| language | Russian |
| last_indexed | 2025-03-14T11:43:01Z |
| publishDate | 2021-12-01 |
| publisher | LLC Center of Pharmaceutical Analytics (LLC «CPHA») |
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| series | Разработка и регистрация лекарственных средств |
| spelling | doaj.art-1ed493a72acf487d8581a573be02eb082025-03-02T09:53:26ZrusLLC Center of Pharmaceutical Analytics (LLC «CPHA»)Разработка и регистрация лекарственных средств2305-20662658-50492021-12-0110411512110.33380/2305-2066-2021-10-4(1)-115-121916The sodium 5-butyl-1,2-diphenyl-6-oxo-1,6-dihydropyrimidine-4-olate quantitative content determination in a standard sampleE. V. Kuvaeva0D. A. Kolesnik1P. O. Levshukova2I. I. Terninko3I. P. Yakovlev4E. V. Fedorova5Saint-Petersburg State Chemical-Pharmaceutical UniversitySaint-Petersburg State Chemical-Pharmaceutical UniversitySaint-Petersburg State Chemical-Pharmaceutical UniversitySaint-Petersburg State Chemical-Pharmaceutical UniversitySaint-Petersburg State Chemical-Pharmaceutical UniversitySaint-Petersburg State Chemical-Pharmaceutical UniversityIntroduction. The standard samples (SS) use is a necessary condition for the medicines' quality control implementation. Their development is an urgent problem for the pharmaceutical industry, especially for new biologically active compounds that can be further used as pharmaceuticals.Aim. This work aim is to establish the 5-butyl-1,2-diphenyl-6-oxo-1,6-dihydro pyrimidone-4-olate sodium quantitative content, for which anti-inflammatory and analgesic activity was previously proven, in a standard sample.Materials and methods. This work aim is to establish the 5-butyl-1,2-diphenyl-6-oxo-1,6-dihydro pyrimidone-4-olate sodium quantitative content, for which anti-inflammatory and analgesic activity was previously proven, in a standard sample. The main method for establishing a substance quantitative content in the SS is the material balance method. The water determination was carried out according to K. Fisher's method (semimicro method). Sulphated ash was determined according to the XIV edition Russian Federation State Pharmacopoeia General Pharmacopoeia Monograph "Sulphated ash". Related impurities and their content were assessed using the HPLC method on a Flexar liquid chromatograph equipped with a diode array detector (Perkin Elmer, USA). The residual solvents' determination was carried out by the headspace method using a gas chromatograph GC-2010Plus Shimadzu with a flame ionization detector. As an additional method for establishing the main component quantitative content, acidimetric titration with the equivalence point potentiometric indication was carried out.Results and discussion. The percentage was determined for the following indicators: water, residual organic solvents, related impurities, sulphated ash. Using the material balance method, it was found that the 5-butyl-1,2-diphenyl-6-oxo-1,6-dihydropyrimidin-4-olate sodium percentage in a standard sample is 96.01 ± 0.50 %. It was found by acidimetric titration that the 5-butyl-1,2-diphenyl-6-oxo 1,6-dihydropyrimidin- 4-olate sodium quantitative content in SS is 95.12 ± 0.02 %. The difference in the certified value can be explained by the fact that during titration, the SS aciform is released, which precipitates in an aqueous medium and contributes to a shift in the equilibrium and pH value. Consequently, the equivalence point is reached somewhat earlier. However, the data are practically comparable, but it is necessary to use the value obtained by the material balance method.Conclusion. A standard sample certification parameters were determined: water content, residual organic solvents, sulphated ash, related impurities. The main component quantitative content was determined using the material balance method and titrimetry (acidimetry with the equivalence point potentiometric indication).https://www.pharmjournal.ru/jour/article/view/1109material balanceacidimetryhydroxyoxopyrimidinesrelated impuritiesresidual solvents |
| spellingShingle | E. V. Kuvaeva D. A. Kolesnik P. O. Levshukova I. I. Terninko I. P. Yakovlev E. V. Fedorova The sodium 5-butyl-1,2-diphenyl-6-oxo-1,6-dihydropyrimidine-4-olate quantitative content determination in a standard sample Разработка и регистрация лекарственных средств material balance acidimetry hydroxyoxopyrimidines related impurities residual solvents |
| title | The sodium 5-butyl-1,2-diphenyl-6-oxo-1,6-dihydropyrimidine-4-olate quantitative content determination in a standard sample |
| title_full | The sodium 5-butyl-1,2-diphenyl-6-oxo-1,6-dihydropyrimidine-4-olate quantitative content determination in a standard sample |
| title_fullStr | The sodium 5-butyl-1,2-diphenyl-6-oxo-1,6-dihydropyrimidine-4-olate quantitative content determination in a standard sample |
| title_full_unstemmed | The sodium 5-butyl-1,2-diphenyl-6-oxo-1,6-dihydropyrimidine-4-olate quantitative content determination in a standard sample |
| title_short | The sodium 5-butyl-1,2-diphenyl-6-oxo-1,6-dihydropyrimidine-4-olate quantitative content determination in a standard sample |
| title_sort | sodium 5 butyl 1 2 diphenyl 6 oxo 1 6 dihydropyrimidine 4 olate quantitative content determination in a standard sample |
| topic | material balance acidimetry hydroxyoxopyrimidines related impurities residual solvents |
| url | https://www.pharmjournal.ru/jour/article/view/1109 |
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