Cleaning Validation Applied to the Production of Antiretroviral Drugs: Determination of Zidovudine and Lamivudine Residues on Manufacturing Equipment
This work evaluated the cleanliness of equipment involved in manufacturing the product LAFEPE Zidovudine (AZT) + Lamivudine (3TC) 300 mg + 150 mg coated tablets in a antiretroviral plant. A method for simultaneous determination of AZT+3TC in High Performance Liquid Chromatography HPLC-UV is selec...
Guardado en:
| Autores principales: | , , , , , , , |
|---|---|
| Formato: | Articulo Comunicacion |
| Lenguaje: | Inglés |
| Publicado: |
2012
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| Materias: | |
| Acceso en línea: | http://sedici.unlp.edu.ar/handle/10915/18143 http://www.latamjpharm.org/resumenes/31/2/LAJOP_31_2_2_3.pdf |
| Aporte de: |
| id |
I19-R120-10915-18143 |
|---|---|
| record_format |
dspace |
| institution |
Universidad Nacional de La Plata |
| institution_str |
I-19 |
| repository_str |
R-120 |
| collection |
SEDICI (UNLP) |
| language |
Inglés |
| topic |
Farmacia cleaning validation; HPLC; lamivudine; swabbing recovery; zidovudine Farmacología |
| spellingShingle |
Farmacia cleaning validation; HPLC; lamivudine; swabbing recovery; zidovudine Farmacología Oliveira, Amanda T. C. Santana, Davi P. Alencar, Joao Rui B. Ribas, Lais A.S. Monteiro, Deborah B. Santos, Bruno A. Oliveira, Antônio D. P. Santana, Aíla K.M. Cleaning Validation Applied to the Production of Antiretroviral Drugs: Determination of Zidovudine and Lamivudine Residues on Manufacturing Equipment |
| topic_facet |
Farmacia cleaning validation; HPLC; lamivudine; swabbing recovery; zidovudine Farmacología |
| description |
This work evaluated the cleanliness of equipment involved in manufacturing the product
LAFEPE Zidovudine (AZT) + Lamivudine (3TC) 300 mg + 150 mg coated tablets in a antiretroviral plant.
A method for simultaneous determination of AZT+3TC in High Performance Liquid Chromatography
HPLC-UV is selective and presented a linear range from 2.5 to 15 μg/mL, and Limit of Detection (LOD)
(AZT: 0.13 μg/mL; 3TC: 0.15 μg/mL) and Limit of Quantification (LOQ) (AZT: 0.20 μg/mL; 3TC: 0.23
μg/mL). Recoveries of 82.00 and 83.00 % for the active AZT and 3TC, respectively, were obtained with
the use of swab on stainless steel surfaces 316L. The method of cleaning and sampling was applied to three
consecutive industrial batches and the results met the specification limits for contaminants. |
| format |
Articulo Comunicacion |
| author |
Oliveira, Amanda T. C. Santana, Davi P. Alencar, Joao Rui B. Ribas, Lais A.S. Monteiro, Deborah B. Santos, Bruno A. Oliveira, Antônio D. P. Santana, Aíla K.M. |
| author_facet |
Oliveira, Amanda T. C. Santana, Davi P. Alencar, Joao Rui B. Ribas, Lais A.S. Monteiro, Deborah B. Santos, Bruno A. Oliveira, Antônio D. P. Santana, Aíla K.M. |
| author_sort |
Oliveira, Amanda T. C. |
| title |
Cleaning Validation Applied to the Production of Antiretroviral Drugs: Determination of Zidovudine and Lamivudine Residues on Manufacturing Equipment |
| title_short |
Cleaning Validation Applied to the Production of Antiretroviral Drugs: Determination of Zidovudine and Lamivudine Residues on Manufacturing Equipment |
| title_full |
Cleaning Validation Applied to the Production of Antiretroviral Drugs: Determination of Zidovudine and Lamivudine Residues on Manufacturing Equipment |
| title_fullStr |
Cleaning Validation Applied to the Production of Antiretroviral Drugs: Determination of Zidovudine and Lamivudine Residues on Manufacturing Equipment |
| title_full_unstemmed |
Cleaning Validation Applied to the Production of Antiretroviral Drugs: Determination of Zidovudine and Lamivudine Residues on Manufacturing Equipment |
| title_sort |
cleaning validation applied to the production of antiretroviral drugs: determination of zidovudine and lamivudine residues on manufacturing equipment |
| publishDate |
2012 |
| url |
http://sedici.unlp.edu.ar/handle/10915/18143 http://www.latamjpharm.org/resumenes/31/2/LAJOP_31_2_2_3.pdf |
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