Percorrer por autor "Silva, Clara"
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- Development and validation of an analytical method to assess the importance of using gauze dressings in luer-lock connection systems during the preparation of cytotoxic drugsPublication . Silva, Clara; Carmo, Helena; Oliveira, Vânia; Carvalho, Daniel; Moreira, Fernando; Moreira, FernandoHealthcare professionals face occupational hazardous when handling cytotoxic drugs used for cancer treatment. The International Society of Oncology Pharmacy Practice (ISOPP) standards are the guidelines recommended by the European Parliament for safety procedures but, unlike others (e.g. Occupational Safety and Health Administration (OSHA)), fail to mention the need to use dressings at luer-lock connections to contain cytotoxic leaks. This study aims to develop and validate an analytical method capable of identifying and quantifying cyclophosphamide (CP) and 5-fluorouracil (5-FU) in gauze dressings. Methods: Gauze dressings (20x10 cm) containing varying concentrations of CP and 5-FU were placed in 15 mL falcons containing acetonitrile:methanol:water (19:13:68). After stirring, the samples were passed through a 0.22 µm filter. The extracted samples were then analyzed using HPLC-DAD, equipped with a C18 column (Hypersil Gold ™ 150mm x 4.6mm and 5µm particle size). The mobile phases employed were acetonitrile:methanol:water (19:13:68) (CP) and 0.5% acetic acid in water (5-FU) and detection was set at 205 nm (CP) and 260 nm (5-FU). The mean of five calibration curves generated for each drug were calculated, each exhibiting R² > 0.997, thus confirming the linearity for both drugs. Regarding sensitivity, LOD of 0.006 µg/cm2 for 5-FU and 0.11 µg/cm2 for CP and LOQs of 0.02 µg/cm2 for 5-FU and 0.32 µg/cm2 for CP, were obtained. Accuracy fell within the range of 93%-110% and precision was set between 91% and 99%. At room temperature, gauze dressings deliberately contaminated exhibited superior stability for 5-FU compared to CP. The method has been successfully validated and, once suitability is confirmed, it will be applicable for the evaluation of the importance of using gauze dressing when handling cytotoxic drugs, by testing contaminations occurring during reallife routine handling of these cytotoxic drugs.
- Development and validation of an analytical method to quantify cytotoxic drugs in gauze dressings used in luer-lock connection systems for a safer preparationPublication . Silva, Clara; Carmo, Helena; Oliveira, Vânia; Carvalho, Daniel; Moreira, FernandoDespite patient ́s benefits, healthcare professionals face occupational hazardous when handling cytotoxic drugs used for cancer treatment. Several organizations outline procedures, conditions, and equipment recommended for safe handling. The International Society of Oncology Pharmacy Practice (ISOPP) standards are the guidelines recommended by the European Parliament but, unlike others (e.g. Occupational Safety and Health Administration (OSHA)), they omit the recommendation of using dressings at luer-lock connections to contain cytotoxic leaks. This study aims to develop and validate an analytical method for cyclophosphamide (CP) and 5-fluorouracil (5-FU) identification and quantification in gauze dressings for monitoring real-life occupational situations. Gauze dressings (20x10 cm) containing varying concentrations of CP and 5-FU were placed in 15 mL falcon tubes containing acetonitrile:methanol:water (19:13:68). After stirring, the samples were filtered through a 0.22 μm filter and analyzed using HPLC-DAD, equipped with a C18 column (Hypersil Gold ™150mm x 4.6mm and 5μm particle size). The mobile phases employed were acetonitrile:methanol:water (19:13:68) (CP) and 0.5% acetic acid in water(for 5-FU), with detection set at 205 nm (CP) and 260 nm (5-FU). The mean of five calibration curves was calculated for each drug, each exhibiting R² > 0.997, confirming the linearity for both drugs. Regarding sensitivity, LOD of 0.006 μg/cm2(5-FU) and 0.11 μg/cm2(CP) and LOQs of 0.02 μg/cm2(5-FU) and 0.32 μg/cm2(CP), were obtained. Accuracy ranged between 93%-110%, while precision ranged between 91%-99%. At room temperature, gauze dressings deliberately contaminated exhibited superior stability for 5-FU compared to CP. The method has been successfully validated for analyzing CP and 5-FU residues in gauze, meeting essential validation criteria. Upon suitability verification, the method will be applicable for the evaluation of the importance of using gauze dressing when handling cytotoxic drugs, by assessing contaminations occurring during their real-life handling routine.