Determination of Anthracycline Drug Residual in Cleaning Validation Swabs of Stainless-Steel Equipment after Production of Cytostatic Injections Using HPLC Analytical Method
Joint Authors
Opatrilova, Radka
Slivová, Zuzana
Source
Issue
Vol. 2015, Issue 2015 (31 Dec. 2015), pp.1-8, 8 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2015-07-12
Country of Publication
Egypt
No. of Pages
8
Main Subjects
Abstract EN
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.
American Psychological Association (APA)
Slivová, Zuzana& Opatrilova, Radka. 2015. 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،Vol. 2015, no. 2015, pp.1-8.
https://search.emarefa.net/detail/BIM-1070353
Modern Language Association (MLA)
Slivová, Zuzana& Opatrilova, Radka. 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 No. 2015 (2015), pp.1-8.
https://search.emarefa.net/detail/BIM-1070353
American Medical Association (AMA)
Slivová, Zuzana& Opatrilova, Radka. 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. 2015. Vol. 2015, no. 2015, pp.1-8.
https://search.emarefa.net/detail/BIM-1070353
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1070353