Please use this identifier to cite or link to this item:
http://nopr.niscpr.res.in/handle/123456789/30088| Title: | Quantitative determination of ciprofloxacin residues for cleaning validation in manufacturing equipment surface |
| Authors: | Shah, Purvi Champaneri, Naitik Solanki, Kamlesh Thakkar, Vaishali Patel, Kalpana Gandhi, Tejal |
| Keywords: | Ciprofloxacin;Cleaning validation;Manufacturing equipment surfaces;Total organic carbon Vcsh analysis;UV spectroscopic method |
| Issue Date: | Jul-2014 |
| Publisher: | NISCAIR-CSIR, India |
| Abstract: | In this study, UV spectroscopic and total organic carbon (TOC) Vcsh 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 µg that should not be exceeded during consecutive equipment cleaning trials. Ciprofloxacin exhibits good linearity in the range 2-10 µg/mL for UV spectroscopic method and 0.25-1.5 µg/mL for TOC Vcsh 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 Vcsh 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. |
| Page(s): | 233-237 |
| ISSN: | 0975-0991 (Online); 0971-457X (Print) |
| Appears in Collections: | IJCT Vol.21(4) [July 2014] |
Files in This Item:
| File | Description | Size | Format | |
|---|---|---|---|---|
| IJCT 21(4) 233-237.pdf | 192.59 kB | Adobe PDF | View/Open |
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