Milenovic D.M.,Zdravlje Actavis Company RandD |
Milosevic S.P.,Zdravlje Actavis Company RandD |
Duric S.L.,Zdravlje Actavis Company RandD |
Naskovic D.C.,Zdravlje Actavis Company RandD |
Mitic S.S.,University of Nis
Journal of Analytical Chemistry | Year: 2013
Analytical method validation, determining the recovery rate from the equipment surface, and stability of a potential contaminant are important steps of a cleaning validation process. An HPLC method for the determination of the verapamil residues on stainless steel surfaces of the equipment employed in drug manufacture is described. The cleaning validation sample impurities as well as excipients of the commercial sample did not interfere in the analysis which proved the selectivity of the method. The validation of the method demonstrated acceptable levels of the linearity, precision and accuracy. Cotton swabs, moistened with methanol were used to remove any residues of drugs from stainless steel surfaces, and give recoveries of above 78.59% for three diferent concentration levels. The precision of the results, reported as the relative standard deviation (RSD, %), were below 1.58%. Low quantities of the drug residues were determined by HPLC using a Hypersil ODS column (125 × 4.0 mm, 5 μm) at 25 °C with the mobile phase metanol-water-triethylamine (70: 30: 0.2, v/v/v) at a flow rate of 0.6 mL/min, injection volume of 50 μL and detection at 278 nm. © 2013 Pleiades Publishing, Ltd.