Abstract
Prevention of cross contamination with active pharmaceutical ingredient is crucial and requires special attention in pharmaceutical industry. Current method validation describes residual determination of olmesartan medoxomil (OLME) on stainless steel surface using swab sampling with a sensitive HPLC-DAD analysis. The acceptance limit was decided as 2μg swab pro 100cm2. Cotton swabs impregnated with extraction solution were used to determine residual drug content. Recoveries were 95.81%, 93.06%, and 96%. 24% with RSD below 1.5% at three concentration levels. Residual concentration was found to be linear in the range of 0.557–5.62μg/mL, when estimated using Phenomenex Luna C18 (25cm×5μm×4.6mm i.d.) column at 1.0mL/min flow rate at 258nm. The mobile phase consisted of a mixture of acetonitrile: methanol: phosphate buffer pH3.5: tetrahydrofuran (28:13:58:1 v/v/v/v). The LOD and LOQ for OLME were found to be 0.07 and 0.22μg/mL, respectively. The validated method was found to be simple, selective and sensitive for demonstration of cleaning validation of OLME residues on the stainless steel surface.
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
