DEVELOPMENT AND VALIDATION OF METHOD OF QUANTITATIVE DETERMINATION OF RESIDUAL ORGANIC SOLVENTS IN INNOVATIVE ACTIVE PHARMACEUTICAL INGREDIENT WITH GC-FID
The aim of the study was to develop and validate a new method of quantitative determination of residual organic solvents in a substance A using GLC. Studies were carried out with gas chromatography with a flame ionization detector and sampling from the vapor phase. The effect of the polarity of the...
| Main Authors: | , , |
|---|---|
| Format: | Article |
| Language: | Russian |
| Published: |
LLC Center of Pharmaceutical Analytics (LLC «CPHA»)
2019-01-01
|
| Series: | Разработка и регистрация лекарственных средств |
| Subjects: | |
| Online Access: | https://www.pharmjournal.ru/jour/article/view/165 |
| _version_ | 1797875054217789440 |
|---|---|
| author | E. V. Butina S. A. Zaitsev A. V. Basevich |
| author_facet | E. V. Butina S. A. Zaitsev A. V. Basevich |
| author_sort | E. V. Butina |
| collection | DOAJ |
| description | The aim of the study was to develop and validate a new method of quantitative determination of residual organic solvents in a substance A using GLC. Studies were carried out with gas chromatography with a flame ionization detector and sampling from the vapor phase. The effect of the polarity of the stationary phase for the chromatographic separation of the organic solvents peaks: Chloroform, Ethanol, Methylene Chloride, Cyclohexane, Ethyl Acetate, Methanol, N, N-dimethylformamide, 2-propanol was investigated. Chromatographic separation of Ethanol, Methanol, 2-propanol, Ethyl Acetate, Methylene Chloride and Cyclohexane was performed with quartz capillary column DB-624, 30 m × 0.20 mm, 1.8 micron; Chloroform and N, N-dimethylformamide – DB-WAX, 30 m × 0.50 mm, 0.25 mm. System suitability criteria and the validity of method were determined. Method has high specificity, precision, linearity, sensitivity and reliability. |
| first_indexed | 2024-04-10T01:41:37Z |
| format | Article |
| id | doaj.art-a7adffe03be143e4ae5c12ad17c24097 |
| institution | Directory Open Access Journal |
| issn | 2305-2066 2658-5049 |
| language | Russian |
| last_indexed | 2024-04-10T01:41:37Z |
| publishDate | 2019-01-01 |
| publisher | LLC Center of Pharmaceutical Analytics (LLC «CPHA») |
| record_format | Article |
| series | Разработка и регистрация лекарственных средств |
| spelling | doaj.art-a7adffe03be143e4ae5c12ad17c240972023-03-13T09:13:57ZrusLLC Center of Pharmaceutical Analytics (LLC «CPHA»)Разработка и регистрация лекарственных средств2305-20662658-50492019-01-0104124128165DEVELOPMENT AND VALIDATION OF METHOD OF QUANTITATIVE DETERMINATION OF RESIDUAL ORGANIC SOLVENTS IN INNOVATIVE ACTIVE PHARMACEUTICAL INGREDIENT WITH GC-FIDE. V. Butina0S. A. Zaitsev1A. V. Basevich2ЗАО «БИОКАД»ЗАО «БИОКАД»ГБОУ ВПО «Санкт-Петербургская государственная химико-фармацевтическая академия» Министерства здравоохранения Российской ФедерацииThe aim of the study was to develop and validate a new method of quantitative determination of residual organic solvents in a substance A using GLC. Studies were carried out with gas chromatography with a flame ionization detector and sampling from the vapor phase. The effect of the polarity of the stationary phase for the chromatographic separation of the organic solvents peaks: Chloroform, Ethanol, Methylene Chloride, Cyclohexane, Ethyl Acetate, Methanol, N, N-dimethylformamide, 2-propanol was investigated. Chromatographic separation of Ethanol, Methanol, 2-propanol, Ethyl Acetate, Methylene Chloride and Cyclohexane was performed with quartz capillary column DB-624, 30 m × 0.20 mm, 1.8 micron; Chloroform and N, N-dimethylformamide – DB-WAX, 30 m × 0.50 mm, 0.25 mm. System suitability criteria and the validity of method were determined. Method has high specificity, precision, linearity, sensitivity and reliability.https://www.pharmjournal.ru/jour/article/view/165остаточные органические растворителивалидацияразработка методикиактивная фармацевтическая субстанция |
| spellingShingle | E. V. Butina S. A. Zaitsev A. V. Basevich DEVELOPMENT AND VALIDATION OF METHOD OF QUANTITATIVE DETERMINATION OF RESIDUAL ORGANIC SOLVENTS IN INNOVATIVE ACTIVE PHARMACEUTICAL INGREDIENT WITH GC-FID Разработка и регистрация лекарственных средств остаточные органические растворители валидация разработка методики активная фармацевтическая субстанция |
| title | DEVELOPMENT AND VALIDATION OF METHOD OF QUANTITATIVE DETERMINATION OF RESIDUAL ORGANIC SOLVENTS IN INNOVATIVE ACTIVE PHARMACEUTICAL INGREDIENT WITH GC-FID |
| title_full | DEVELOPMENT AND VALIDATION OF METHOD OF QUANTITATIVE DETERMINATION OF RESIDUAL ORGANIC SOLVENTS IN INNOVATIVE ACTIVE PHARMACEUTICAL INGREDIENT WITH GC-FID |
| title_fullStr | DEVELOPMENT AND VALIDATION OF METHOD OF QUANTITATIVE DETERMINATION OF RESIDUAL ORGANIC SOLVENTS IN INNOVATIVE ACTIVE PHARMACEUTICAL INGREDIENT WITH GC-FID |
| title_full_unstemmed | DEVELOPMENT AND VALIDATION OF METHOD OF QUANTITATIVE DETERMINATION OF RESIDUAL ORGANIC SOLVENTS IN INNOVATIVE ACTIVE PHARMACEUTICAL INGREDIENT WITH GC-FID |
| title_short | DEVELOPMENT AND VALIDATION OF METHOD OF QUANTITATIVE DETERMINATION OF RESIDUAL ORGANIC SOLVENTS IN INNOVATIVE ACTIVE PHARMACEUTICAL INGREDIENT WITH GC-FID |
| title_sort | development and validation of method of quantitative determination of residual organic solvents in innovative active pharmaceutical ingredient with gc fid |
| topic | остаточные органические растворители валидация разработка методики активная фармацевтическая субстанция |
| url | https://www.pharmjournal.ru/jour/article/view/165 |
| work_keys_str_mv | AT evbutina developmentandvalidationofmethodofquantitativedeterminationofresidualorganicsolventsininnovativeactivepharmaceuticalingredientwithgcfid AT sazaitsev developmentandvalidationofmethodofquantitativedeterminationofresidualorganicsolventsininnovativeactivepharmaceuticalingredientwithgcfid AT avbasevich developmentandvalidationofmethodofquantitativedeterminationofresidualorganicsolventsininnovativeactivepharmaceuticalingredientwithgcfid |