Development and Validation of Conditions for the Determination of Residual Organic Solvents – Acetic Acid in the Silver Salt Substance 4-[4-(atsetilaminosul'fonil)fenil]-6-(4-bromfenil)-5-(2-nitrofenil)-3,5-digidropirrolo[3,4-с]pirazol-3-ona
Introduction. For new synthesized pharmacologically active compounds, already at the stage of standardization, it is necessary to develop methods for determining their quality indicators, normalized by a pharmacopoeial article for pharmaceutical substances. One of these indicators is the residual or...
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LLC Center of Pharmaceutical Analytics (LLC «CPHA»)
2022-12-01
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| Series: | Разработка и регистрация лекарственных средств |
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| Online Access: | https://www.pharmjournal.ru/jour/article/view/1401 |
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| author | E. N. Lyust O. V. Bobrovskaya V. L. Gein |
| author_facet | E. N. Lyust O. V. Bobrovskaya V. L. Gein |
| author_sort | E. N. Lyust |
| collection | DOAJ |
| description | Introduction. For new synthesized pharmacologically active compounds, already at the stage of standardization, it is necessary to develop methods for determining their quality indicators, normalized by a pharmacopoeial article for pharmaceutical substances. One of these indicators is the residual organic solvents, for the analysis of which chromatographic methods are suitable, for example, gas-liquid chromatography.Aim. To develop conditions for the determination of residual organic solvents - acetic acid in a new pharmacologically active compound (substance of silver salt 4-[4-(acetylaminosulfonyl)phenyl]-6-(4-bromophenyl)-5-(2-nitrophenyl)-3,5-dihydropyrrolo[3,4-c]pyrazol-3-one), to validate the developed method.Materials and methods. The substance of the silver salt 4-[4-(acetylaminosulfonyl)phenyl]-6-(4-bromophenyl)-5-(2-nitrophenyl)-3,5-dihydropyrrolo[3,4-c]pyrazole-3-one, synthesized at the Perm State Pharmaceutical Academy. The study was carried out by the gas chromatographic method (gas-liquid chromatograph Chromatec-Crystal 5000, JSC SDO «Chromatec», Russia).Results and discussion. This paper reflects the results of the choice of gas chromatographic conditions for determining the residual organic solvent (acetic acid) in the substance, these conditions are evaluated according to the validation indicators required for analytical methods.Conclusion. A procedure has been developed for determining the residual organic solvent in the substance of the silver salt 4-[4-(acetylaminosulfonyl)phenyl]-6-(4-bromophenyl)-5-(2-nitrophenyl)-3,5-dihydropyrrolo[3,4-c]pyrazole-3-one, the methodology was validated. |
| format | Article |
| id | doaj-art-e5d785ac476641a48c3480694baa4049 |
| institution | Kabale University |
| issn | 2305-2066 2658-5049 |
| language | Russian |
| publishDate | 2022-12-01 |
| publisher | LLC Center of Pharmaceutical Analytics (LLC «CPHA») |
| record_format | Article |
| series | Разработка и регистрация лекарственных средств |
| spelling | doaj-art-e5d785ac476641a48c3480694baa40492025-08-20T03:39:45ZrusLLC Center of Pharmaceutical Analytics (LLC «CPHA»)Разработка и регистрация лекарственных средств2305-20662658-50492022-12-01114737810.33380/2305-2066-2022-11-4(1)-73-781054Development and Validation of Conditions for the Determination of Residual Organic Solvents – Acetic Acid in the Silver Salt Substance 4-[4-(atsetilaminosul'fonil)fenil]-6-(4-bromfenil)-5-(2-nitrofenil)-3,5-digidropirrolo[3,4-с]pirazol-3-onaE. N. Lyust0O. V. Bobrovskaya1V. L. Gein2Federal State Budgetary Educational Institution of Higher Education "Perm State Pharmaceutical Academy" of the Ministry of Health of the Russian FederationFederal State Budgetary Educational Institution of Higher Education "Perm State Pharmaceutical Academy" of the Ministry of Health of the Russian FederationFederal State Budgetary Educational Institution of Higher Education "Perm State Pharmaceutical Academy" of the Ministry of Health of the Russian FederationIntroduction. For new synthesized pharmacologically active compounds, already at the stage of standardization, it is necessary to develop methods for determining their quality indicators, normalized by a pharmacopoeial article for pharmaceutical substances. One of these indicators is the residual organic solvents, for the analysis of which chromatographic methods are suitable, for example, gas-liquid chromatography.Aim. To develop conditions for the determination of residual organic solvents - acetic acid in a new pharmacologically active compound (substance of silver salt 4-[4-(acetylaminosulfonyl)phenyl]-6-(4-bromophenyl)-5-(2-nitrophenyl)-3,5-dihydropyrrolo[3,4-c]pyrazol-3-one), to validate the developed method.Materials and methods. The substance of the silver salt 4-[4-(acetylaminosulfonyl)phenyl]-6-(4-bromophenyl)-5-(2-nitrophenyl)-3,5-dihydropyrrolo[3,4-c]pyrazole-3-one, synthesized at the Perm State Pharmaceutical Academy. The study was carried out by the gas chromatographic method (gas-liquid chromatograph Chromatec-Crystal 5000, JSC SDO «Chromatec», Russia).Results and discussion. This paper reflects the results of the choice of gas chromatographic conditions for determining the residual organic solvent (acetic acid) in the substance, these conditions are evaluated according to the validation indicators required for analytical methods.Conclusion. A procedure has been developed for determining the residual organic solvent in the substance of the silver salt 4-[4-(acetylaminosulfonyl)phenyl]-6-(4-bromophenyl)-5-(2-nitrophenyl)-3,5-dihydropyrrolo[3,4-c]pyrazole-3-one, the methodology was validated.https://www.pharmjournal.ru/jour/article/view/1401substancestandardizationresidual organic solventsgas-liquid chromatographyvalidation |
| spellingShingle | E. N. Lyust O. V. Bobrovskaya V. L. Gein Development and Validation of Conditions for the Determination of Residual Organic Solvents – Acetic Acid in the Silver Salt Substance 4-[4-(atsetilaminosul'fonil)fenil]-6-(4-bromfenil)-5-(2-nitrofenil)-3,5-digidropirrolo[3,4-с]pirazol-3-ona Разработка и регистрация лекарственных средств substance standardization residual organic solvents gas-liquid chromatography validation |
| title | Development and Validation of Conditions for the Determination of Residual Organic Solvents – Acetic Acid in the Silver Salt Substance 4-[4-(atsetilaminosul'fonil)fenil]-6-(4-bromfenil)-5-(2-nitrofenil)-3,5-digidropirrolo[3,4-с]pirazol-3-ona |
| title_full | Development and Validation of Conditions for the Determination of Residual Organic Solvents – Acetic Acid in the Silver Salt Substance 4-[4-(atsetilaminosul'fonil)fenil]-6-(4-bromfenil)-5-(2-nitrofenil)-3,5-digidropirrolo[3,4-с]pirazol-3-ona |
| title_fullStr | Development and Validation of Conditions for the Determination of Residual Organic Solvents – Acetic Acid in the Silver Salt Substance 4-[4-(atsetilaminosul'fonil)fenil]-6-(4-bromfenil)-5-(2-nitrofenil)-3,5-digidropirrolo[3,4-с]pirazol-3-ona |
| title_full_unstemmed | Development and Validation of Conditions for the Determination of Residual Organic Solvents – Acetic Acid in the Silver Salt Substance 4-[4-(atsetilaminosul'fonil)fenil]-6-(4-bromfenil)-5-(2-nitrofenil)-3,5-digidropirrolo[3,4-с]pirazol-3-ona |
| title_short | Development and Validation of Conditions for the Determination of Residual Organic Solvents – Acetic Acid in the Silver Salt Substance 4-[4-(atsetilaminosul'fonil)fenil]-6-(4-bromfenil)-5-(2-nitrofenil)-3,5-digidropirrolo[3,4-с]pirazol-3-ona |
| title_sort | development and validation of conditions for the determination of residual organic solvents acetic acid in the silver salt substance 4 4 atsetilaminosul fonil fenil 6 4 bromfenil 5 2 nitrofenil 3 5 digidropirrolo 3 4 с pirazol 3 ona |
| topic | substance standardization residual organic solvents gas-liquid chromatography validation |
| url | https://www.pharmjournal.ru/jour/article/view/1401 |
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