Determination of Anthracycline Drug Residual in Cleaning Validation Swabs of Stainless-Steel Equipment after Production of Cytostatic Injections Using HPLC Analytical Method. (12th July 2015)

• Record Type: Journal Article
• Authors: Slivová, Zuzana; Opatřilová, Radka
• Other Names: Kim Jeongkwon Academic Editor.
• Is Part Of: Journal of spectroscopy. Volume 2015(2015)
• Publication Date: 2015-07-12
• Subjects: Spectrum analysis -- Periodicals; 543.505
• DOI: 10.1155/2015/847349
• Languages: English
• ISSNs: 2314-4920

Abstract

Abstract : 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 μ g/100 cm 2 . Recovery from the stainless-steel surface was 90.1%. Linearity of the method was observed in the concentration range of 0.155–194 μ g/mL when estimated using Zorbax TMS (5 μ m, 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 μ g/mL, respectively. The method validation confirmed the method provides acceptable degree of selectivity, linearity, accuracy, and precision for the intended purposes.