Determination of Anthracycline Drug Residual in Cleaning Validation Swabs of Stainless-Steel Equipment after Production of Cytostatic Injections Using HPLC Analytical Method
Standard cleaning procedures of production line equipment were verified after manufacture of cytostatic injections containing Anthracycline derivate substance. Residual content of Anthracycline drug substance on stainless-steel equipment surface was determined using swab sampling with a specific HPL...
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| Format: | Article |
| Language: | English |
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Wiley
2015-01-01
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| Series: | Journal of Spectroscopy |
| Online Access: | http://dx.doi.org/10.1155/2015/847349 |
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| author | Zuzana Slivová Radka Opatřilová |
| author_facet | Zuzana Slivová Radka Opatřilová |
| author_sort | Zuzana Slivová |
| collection | DOAJ |
| description | Standard cleaning procedures of production line equipment were verified after manufacture of cytostatic injections containing Anthracycline derivate substance. Residual content of Anthracycline drug substance on stainless-steel equipment surface was determined using swab sampling with a specific HPLC-DAD analysis. The acceptance limit was decided as 200.0 μg/100 cm2. Recovery from the stainless-steel surface was 90.1%. Linearity of the method was observed in the concentration range of 0.155–194 μg/mL when estimated using Zorbax TMS (5 μm, 0.25 m × 4.6 mm ID) column at 1.3 mL/min flow rate and 254 nm (DAD 190–600 nm). The mobile phase consisted of lauryl hydrogen sulphate solution (3.7 g/L) : methanol : acetonitrile (54 : 16 : 30, v/v/v) with pH adjusted to 2.5 using phosphoric acid (85%). The LOD and LOQ for Anthracycline derivate were found to be 0.047 and 0.155 μg/mL, respectively. The method validation confirmed the method provides acceptable degree of selectivity, linearity, accuracy, and precision for the intended purposes. |
| format | Article |
| id | doaj-art-2e7352d0470646ebaffa15a0fb5701ac |
| institution | Kabale University |
| issn | 2314-4920 2314-4939 |
| language | English |
| publishDate | 2015-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Spectroscopy |
| spelling | doaj-art-2e7352d0470646ebaffa15a0fb5701ac2025-02-03T01:26:18ZengWileyJournal of Spectroscopy2314-49202314-49392015-01-01201510.1155/2015/847349847349Determination of Anthracycline Drug Residual in Cleaning Validation Swabs of Stainless-Steel Equipment after Production of Cytostatic Injections Using HPLC Analytical MethodZuzana Slivová0Radka Opatřilová1oncomed manufacturing a.s., Karásek 1229/1b, 62100 Brno, Czech RepublicDepartment of Chemical Drugs, Faculty of Pharmacy, University of Veterinary and Pharmaceutical Sciences Brno, Palackého 1-3, 61242 Brno, Czech RepublicStandard cleaning procedures of production line equipment were verified after manufacture of cytostatic injections containing Anthracycline derivate substance. Residual content of Anthracycline drug substance on stainless-steel equipment surface was determined using swab sampling with a specific HPLC-DAD analysis. The acceptance limit was decided as 200.0 μg/100 cm2. Recovery from the stainless-steel surface was 90.1%. Linearity of the method was observed in the concentration range of 0.155–194 μg/mL when estimated using Zorbax TMS (5 μm, 0.25 m × 4.6 mm ID) column at 1.3 mL/min flow rate and 254 nm (DAD 190–600 nm). The mobile phase consisted of lauryl hydrogen sulphate solution (3.7 g/L) : methanol : acetonitrile (54 : 16 : 30, v/v/v) with pH adjusted to 2.5 using phosphoric acid (85%). The LOD and LOQ for Anthracycline derivate were found to be 0.047 and 0.155 μg/mL, respectively. The method validation confirmed the method provides acceptable degree of selectivity, linearity, accuracy, and precision for the intended purposes.http://dx.doi.org/10.1155/2015/847349 |
| spellingShingle | Zuzana Slivová Radka Opatřilová Determination of Anthracycline Drug Residual in Cleaning Validation Swabs of Stainless-Steel Equipment after Production of Cytostatic Injections Using HPLC Analytical Method Journal of Spectroscopy |
| title | Determination of Anthracycline Drug Residual in Cleaning Validation Swabs of Stainless-Steel Equipment after Production of Cytostatic Injections Using HPLC Analytical Method |
| title_full | Determination of Anthracycline Drug Residual in Cleaning Validation Swabs of Stainless-Steel Equipment after Production of Cytostatic Injections Using HPLC Analytical Method |
| title_fullStr | Determination of Anthracycline Drug Residual in Cleaning Validation Swabs of Stainless-Steel Equipment after Production of Cytostatic Injections Using HPLC Analytical Method |
| title_full_unstemmed | Determination of Anthracycline Drug Residual in Cleaning Validation Swabs of Stainless-Steel Equipment after Production of Cytostatic Injections Using HPLC Analytical Method |
| title_short | Determination of Anthracycline Drug Residual in Cleaning Validation Swabs of Stainless-Steel Equipment after Production of Cytostatic Injections Using HPLC Analytical Method |
| title_sort | determination of anthracycline drug residual in cleaning validation swabs of stainless steel equipment after production of cytostatic injections using hplc analytical method |
| url | http://dx.doi.org/10.1155/2015/847349 |
| work_keys_str_mv | AT zuzanaslivova determinationofanthracyclinedrugresidualincleaningvalidationswabsofstainlesssteelequipmentafterproductionofcytostaticinjectionsusinghplcanalyticalmethod AT radkaopatrilova determinationofanthracyclinedrugresidualincleaningvalidationswabsofstainlesssteelequipmentafterproductionofcytostaticinjectionsusinghplcanalyticalmethod |