环丙沙星片--Ciprofloxacin-Tablets-BP2009.pdf

Browse: British Pharmacopoeia 2009 British Pharmacopoeia Volume III Formulated Preparations: Specific Monographs Ciprofloxacin Tablets Ciprofloxacin Tablets General Notices Action and use Fluoroquinolone antibacterial. DEFINITION Ciprofloxacin Tablets contain Ciprofloxacin Hydrochloride. The tablets comply with the requirements stated under Tablets and with the following requirements. Content of ciprofloxacin, C H FN O 17 18 3 3 95.0 to 105.0% of the stated amount. IDENTIFICATION A. Carry out the method for thin-layer chromatography, Appendix III A, using a silica gel F 254 high-performance precoated plate (Merck silica gel 60 F254 HPTLC plates are suitable) and a mixture of 10 volumes of acetonitrile, 20 volumes of 13.5M ammonia, 40 volumes of dichloromethane and 40 volumes of methanol as the mobile phase. Apply separately to the plate, as bands, 10 µl of each of the following solutions. For solution (1) use solution (1) described under Assay. Solution (2) contains 0.058% w/v of ciprofloxacin hydrochloride EPCRS in water. For solution (3) mix 1 volume of solution (1) and 1 volume of solution (2). After removal of the plate, allow it to dry in air for 15 minutes and examine under ultraviolet light (254 nm and 365 nm). The principal band in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2). The principal band in the chromatogram obtained with solution (3) appears as a single, compact band. B. In the Assay, the retention time of the principal peak in the chromatogram obtained with solution (1) is the same as that of the principal peak in the chromatogram obtained with solution (2). TESTS Dissolution Comply with the requirements for Monographs