Ciprofloxacin Tablets
Action and use
Fluoroquinolone antibacterial.
Definition
Ciprofloxacin Tablets contain Ciprofloxacin Hydrochloride.
Content of ciprofloxacin, C17H18FN3O3
95.0 to 105.0% of the stated amount.
Identification
10 volumes of acetonitrile, 20 volumes of 13.5m ammonia, 40 volumes of dichloromethane and 40 volumes of methanol.
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.
Tests
Dissolution
Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1.
Calculate the total content of ciprofloxacin, C17H18FN3O3, in the medium from the absorbances obtained and from the declared content of C17H18FN3O3,HCl in ciprofloxacin hydrochloride BPCRS. Each mg of C17H18FN3O3,HCl is equivalent to 0.9010 mg of C17H18FN3O3.
The amount of ciprofloxacin released is not less than 80% of the stated amount.
Related substances
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
The chromatographic conditions described under Assay may be used.
For solution (1) allow the chromatography to proceed for 2.3 times the retention time of ciprofloxacin.
When the chromatograms are recorded under the prescribed conditions the retention time of ciprofloxacin is about 9 minutes. Retention times relative to ciprofloxacin are: impurity E, about 0.4; impurity F, about 0.5; impurity B, about 0.6; impurity C, about 0.7; impurity D, about 1.2.
The test is not valid unless, in the chromatogram obtained with solution (2), the resolution factor between the peaks due to ciprofloxacin impurity B and ciprofloxacin impurity C is at least 1.3.
Identify any peaks in the chromatogram obtained with solution (1) corresponding to ciprofloxacin impurities B, C, D and E using solution (2) and multiply the area of these peaks by the following correction factors: 0.7, 0.6, 1.4 and 6.7 respectively.
In the chromatogram obtained with solution (1):
the area of any peak corresponding to 7-[(2-aminoethyl)amino]-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxoquinoline-3-carboxylic acid (ciprofloxacin impurity C) is not greater than the area of the principal peak in the chromatogram obtained with solution (3) (0.5%);
the area of any peak corresponding to 1-cyclopropyl-6-fluoro-7-(piperazin-1-yl)quinolin-4(1H)-one (ciprofloxacin impurity E) is not greater than 1.5 times the area of the principal peak in the chromatogram obtained with solution (4) (0.3%);
the area of any other secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (4) (0.2%);
the sum of the areas of all the secondary peaks, excluding the peak corresponding to ciprofloxacin impurity C, is not greater than the area of the principal peak in the chromatogram obtained with solution (3) (0.5%).
Disregard any peak with an area less than 0.25 times the area of the principal peak in the chromatogram obtained with solution (4) (0.05%).
Assay
Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
13 volumes of acetonitrile and 87 volumes of a 0.245% w/v solution of orthophosphoric acid the pH of which has been adjusted to 3.0 with triethylamine.
Calculate the content of C17H18FN3O3 in the tablets using the declared content of C17H18FN3O3,HCl in ciprofloxacin hydrochloride BPCRS. Each mg of C17H18FN3O3,HCl is equivalent to 0.9010 mg of C17H18FN3O3.
Labelling
The quantity of active ingredient is stated in terms of the equivalent amount of ciprofloxacin.
Impurities
The impurities limited by the requirements of this monograph include impurities B, C, D, E and F listed under Ciprofloxacin Hydrochloride.