RT Journal Article
SR Electronic
T1 Cleaning validation for residual estimation of mometasone furoate on stainless steel surface of pharmaceutical manufacturing equipment using a UHPLC-UV method
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2018.009712
DO 10.5731/pdajpst.2018.009712
A1 Ana Silva Coelho
A1 Raquel Gregorio Arribada
A1 Eduardo Lages
YR 2019
UL http://journal.pda.org/content/early/2019/08/16/pdajpst.2018.009712.abstract
AB Cleaning validation is the documented evidence that shows the effectiveness of cleaning procedures for the removal of product residues and other contaminants. The cleaning procedures must be validated and methods to determine trace amounts of drugs have to be considered with special attention. A UHPLC-UV method for the determination of mometasone furoate residues on stainless steel surfaces was developed and validated in order to control a cleaning procedure. The chromatography separation was achieved on a Waters Acquity UPLC HSS T3 column (50 x 2.1 mm, 1.8 µm), at 40 °C, using acetonitrile and water (1:1, v/v) as the mobile phase at a flow rate of 0.5 mL/min. The injection volume was 2 µL and the detection was performed at 254 nm. The swab and rinse procedures were optimized in order to obtain a recovery higher than 90% of mometasone furoate from stainless steel surfaces, using ethanol as the extraction solvent. The method was validated in the range of 0.2 to 2.6 µg/mL and showed appropriate selectivity, limit of detection and quantification, linearity, precision, accuracy, and robustness. This method was found to be simple, fast and sensitive for determination of mometasone furoate residues and, therefore, can be used for cleaning validation analysis.