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Indian Journal of Chemical Technology, Vol.21, No.4, 233-237, 2014
Quantitative determination of ciprofloxacin residues for cleaning validation in manufacturing equipment surface
In this study, UV spectroscopic and total organic carbon (TOC) V-csh methods have been developed and validated for the determination of trace amount of ciprofloxacin residues on the manufacturing equipment surfaces and to confirm the efficiency of the cleaning procedure. Ciprofloxacin has been selected on the basis of worst case rating approach. The established limit of contamination value for ciprofloxacin is found to be 36.27 lug that should not be exceeded during consecutive equipment cleaning trials. Ciprofloxacin exhibits good linearity in the range 2-10 mu g/mL for UV spectroscopic method and 0.25-1.5 mu g/mL for TOC V-csh analysis. Percentage recovery from spiked stainless steel plate using swab sampling technique is found in the limit of 90.74% and 91.19 % in UV spectroscopic and TOC Vesh method respectively. Both methods are simple, cheap and less time consuming as well as suitable for quantitative determination of ciprofloxacin on manufacturing equipment surfaces well below the limit of contamination. The validated methods are found to be satisfactory for the demonstration of-cleaning validation of ciprofloxacin residue on manufacturing equipment surface.
Keywords:Ciprofloxacin;Cleaning validation;Manufacturing equipment surfaces;Total organic carbon V-csh analysis;UV spectroscopic method