Luminescent determination of residues of trazodon hydrochloride and melatonin after cleaning pharmaceutical equipment
A prerequisite for ensuring the quality of medicines is their production in accordance with the rules of GMP (Good Manufacturing Practice for Medicinal Products), one of the most important requirements of which is equipment cleaning. In many cases, the same equipment is used in the production of var...
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | Ukrainian |
| Published: |
The State Expert Center of the Ministry of Health of Ukraine
2019-09-01
|
| Series: | Фармацевтичний журнал |
| Subjects: | |
| Online Access: | https://pharmj.org.ua/index.php/journal/article/view/620/583 |
| _version_ | 1818336881904975872 |
|---|---|
| author | O. D. Voitiuk A. V. Yegorova Yu. V. Scrypynets S. N. Kashutskуy V. P. Antonovich |
| author_facet | O. D. Voitiuk A. V. Yegorova Yu. V. Scrypynets S. N. Kashutskуy V. P. Antonovich |
| author_sort | O. D. Voitiuk |
| collection | DOAJ |
| description | A prerequisite for ensuring the quality of medicines is their production in accordance with the rules of GMP (Good Manufacturing Practice for Medicinal Products), one of the most important requirements of which is equipment cleaning. In many cases, the same equipment is used in the production of various preparations. Therefore, to prevent contamination of each of the following drugs, the previous one, it is very important to carry out an effective equipment cleaning procedure with a mandatory assessment of its purity.
The purpose of this study was to develop simple, express, selective methods for luminescent determination of residual quantities of APIs of trazodone hydrochloride (TG) and melatonin (MT) in washes to control the completeness of their removal when cleaning process equipment.
The excitation and luminescence spectra were recorded using a Cary Eclipse "Varian" spectrofluorimeter (Australia) with a xenon lamp 150 W. Electronic absorption spectra were recorded on a UV-2401 PC spectrophotometer «Shimadzu» (Japan).
The electronic absorption spectra of TG and MT have absorption bands in the UV spectral region. It was established experimentally that the excitation spectra of TG and MT are similar to their absorption spectra (λex = 318 nm (TG) and λem = 274 nm (MT)). The effect on the luminescence intensity of TG and MT of methanol, ethanol, acetonitrile, dimethylformamide, dimethylsulfoxide, propanol (50 v/v) was studied. It is established that the maximum luminescence is observed in water.
The methods were validated according to the following parameters: specificity, linearity, accuracy, limit of quantitation. The degree of extraction of trazodone hydrochloride and melatonin from applicators and surfaces of pharmaceutical equipment is more than 90%. The developed methods can be recommended for determining the residual amounts of trazodone hydrochloride and melatonin while monitoring the quality of the cleaning of pharmaceutical equipment. |
| first_indexed | 2024-12-13T14:46:22Z |
| format | Article |
| id | doaj.art-0032d1e821a1493688597f77ab8fb249 |
| institution | Directory Open Access Journal |
| issn | 0367-3057 2617-9628 |
| language | Ukrainian |
| last_indexed | 2024-12-13T14:46:22Z |
| publishDate | 2019-09-01 |
| publisher | The State Expert Center of the Ministry of Health of Ukraine |
| record_format | Article |
| series | Фармацевтичний журнал |
| spelling | doaj.art-0032d1e821a1493688597f77ab8fb2492022-12-21T23:41:27ZukrThe State Expert Center of the Ministry of Health of UkraineФармацевтичний журнал0367-30572617-96282019-09-0144738110.32352/0367-3057.4.19.08Luminescent determination of residues of trazodon hydrochloride and melatonin after cleaning pharmaceutical equipmentO. D. Voitiuk0A. V. Yegorova1Yu. V. Scrypynets2S. N. Kashutskуy3V. P. Antonovich4«INTERCHEM SLC», OdesaBogatsky Physico-chemical Institute of the National Academy of Sciences of Ukraine, OdesaBogatsky Physico-chemical Institute of the National Academy of Sciences of Ukraine, Odesa«INTERCHEM SLC», OdesaBogatsky Physico-chemical Institute of the National Academy of Sciences of Ukraine, OdesaA prerequisite for ensuring the quality of medicines is their production in accordance with the rules of GMP (Good Manufacturing Practice for Medicinal Products), one of the most important requirements of which is equipment cleaning. In many cases, the same equipment is used in the production of various preparations. Therefore, to prevent contamination of each of the following drugs, the previous one, it is very important to carry out an effective equipment cleaning procedure with a mandatory assessment of its purity. The purpose of this study was to develop simple, express, selective methods for luminescent determination of residual quantities of APIs of trazodone hydrochloride (TG) and melatonin (MT) in washes to control the completeness of their removal when cleaning process equipment. The excitation and luminescence spectra were recorded using a Cary Eclipse "Varian" spectrofluorimeter (Australia) with a xenon lamp 150 W. Electronic absorption spectra were recorded on a UV-2401 PC spectrophotometer «Shimadzu» (Japan). The electronic absorption spectra of TG and MT have absorption bands in the UV spectral region. It was established experimentally that the excitation spectra of TG and MT are similar to their absorption spectra (λex = 318 nm (TG) and λem = 274 nm (MT)). The effect on the luminescence intensity of TG and MT of methanol, ethanol, acetonitrile, dimethylformamide, dimethylsulfoxide, propanol (50 v/v) was studied. It is established that the maximum luminescence is observed in water. The methods were validated according to the following parameters: specificity, linearity, accuracy, limit of quantitation. The degree of extraction of trazodone hydrochloride and melatonin from applicators and surfaces of pharmaceutical equipment is more than 90%. The developed methods can be recommended for determining the residual amounts of trazodone hydrochloride and melatonin while monitoring the quality of the cleaning of pharmaceutical equipment.https://pharmj.org.ua/index.php/journal/article/view/620/583luminescencetrazodone hydrochloridemelatonincleaning of pharmaceutical equipment |
| spellingShingle | O. D. Voitiuk A. V. Yegorova Yu. V. Scrypynets S. N. Kashutskуy V. P. Antonovich Luminescent determination of residues of trazodon hydrochloride and melatonin after cleaning pharmaceutical equipment Фармацевтичний журнал luminescence trazodone hydrochloride melatonin cleaning of pharmaceutical equipment |
| title | Luminescent determination of residues of trazodon hydrochloride and melatonin after cleaning pharmaceutical equipment |
| title_full | Luminescent determination of residues of trazodon hydrochloride and melatonin after cleaning pharmaceutical equipment |
| title_fullStr | Luminescent determination of residues of trazodon hydrochloride and melatonin after cleaning pharmaceutical equipment |
| title_full_unstemmed | Luminescent determination of residues of trazodon hydrochloride and melatonin after cleaning pharmaceutical equipment |
| title_short | Luminescent determination of residues of trazodon hydrochloride and melatonin after cleaning pharmaceutical equipment |
| title_sort | luminescent determination of residues of trazodon hydrochloride and melatonin after cleaning pharmaceutical equipment |
| topic | luminescence trazodone hydrochloride melatonin cleaning of pharmaceutical equipment |
| url | https://pharmj.org.ua/index.php/journal/article/view/620/583 |
| work_keys_str_mv | AT odvoitiuk luminescentdeterminationofresiduesoftrazodonhydrochlorideandmelatoninaftercleaningpharmaceuticalequipment AT avyegorova luminescentdeterminationofresiduesoftrazodonhydrochlorideandmelatoninaftercleaningpharmaceuticalequipment AT yuvscrypynets luminescentdeterminationofresiduesoftrazodonhydrochlorideandmelatoninaftercleaningpharmaceuticalequipment AT snkashutskuy luminescentdeterminationofresiduesoftrazodonhydrochlorideandmelatoninaftercleaningpharmaceuticalequipment AT vpantonovich luminescentdeterminationofresiduesoftrazodonhydrochlorideandmelatoninaftercleaningpharmaceuticalequipment |