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Category Antibacterial.
          Ciprofloxacin Hydrochloride Tablets contain Ciprofloxacin Hydrochloride equivalent to not less than 90.0 per cent and not more than 110.0 per cent of the labelled amount of C₁₇H₁₈FN₃O₃.

Strengths available 100, 250, 500, 750, and 1000 mg (base).

Dose Adults----Anthrax: 500 mg every 12 hours.
          Bone and joint infections; lower respiratory tract infection; skin and skin structure infection: 500 mg every 12 hours for 7 to 14 days. Severe or complicated infections: 750 mg every 12 hours for 7 to 14 days.
          Diarrhea, bacterial: 500 mg every 12 hours for 5 to 7 days.
          Traveler’s diarrhea: 500 mg every 12 hours for 1 to 3 days
          Gonorrhea, endocervical and urethral: 250 to 500 mg as a single dose.
          Typhoid fever: 500 mg every 12 hours for 10 days.
          Urinary tract infection, acute and uncomplicated: 250 mg every 12 hours for 3 days. Urinary tract infection, complicated and pyelonephritis: 250 mg every 12 hours for 7 to 14 days. Severe complication: 500 mg every 12 hours for 7 to 14 days.
          The maximum total dose should not exceed 1.5 g daily.
          Adolescents and children: when alternative therapy could not be used, 10 to 20 mg per kg of body weight every 12 hours.
          Anthrax: 10 to 15 mg per kg of body weight every 12 hours.
          The maximum total dose should not exceed 1 g daily.

Contra-indication; Warning; Precaution; Additional information See under Norfloxacin, p. 133.

Labelling The label on the container states the quantity equivalent to the amount of ciprofloxacin.

Identification
          A. Carry out the test as described in the “Thin-layer chromatography” (Appendix 3.1), using silica gel GF254 as the coating substance and a mixture of 4 volumes of dichloromethane, 4 volumes of methanol, 2 volumes of strong ammonia solution, and 1 volume of acetonitrile as the mobile phase. Place the plate in an atmosphere of ammonia for 15 minutes before use. Apply separately to the plate, 10 μl of each of the following solutions. For solution (A), place a number of the tablets, equivalent to 1.5 g of ciprofloxacin, in a suitable flask containing 750 ml of water, and sonicate for 20 minutes. Dilute with water to 1000.0 ml and mix. Centrifuge a portion of this suspension, and use the clear supernatant obtained as the test solution. Solution (B) is 1.5 mg per ml of Ciprofloxacin Hydrochloride RS in water. After removal of the plate, allow it to dry in air for 15 minutes and examine under ultraviolet light (254 nm and 366 nm). The principal spot in the chromatogram obtained from solution (A) corresponds to that obtained from solution (B).
          B. The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.

Dissolution Carry out the test as described in the “Dissolution Test” (Appendix 4.24).
          Dissolution medium: 0.01 M hydrochloric acid; 900 ml.
          Apparatus 2: 50 rpm.
          Time: 30 minutes.
          Procedure Determine the amount of C₁₇H₁₈FN₃O₃.HCl dissolved from absorbances at the maximum at about 276 nm of filtered portions of the test solution, suitably diluted with Dissolution medium, if necessary, in comparison with a standard solution having a known concentration of Ciprofloxacin Hydrochloride RS in the same medium (Appendix 2.2).
          Tolerances Not less than 80 per cent (Q) of the labelled amount of C₁₇H₁₈FN₃O₃ is dissolved in 30 minutes.

Assay Carry out the determination as described in the “High-pressure Liquid Chromatography” (Appendix 3.5).
          Diluent Prepare a mixture of 87 volumes of 0.025 M phosphoric acid, previously adjusted with triethylamine to a pH of 2.0±0.1, and 13 volumes of acetonitrile.
          Mobile phase Prepare a mixture of 87 volumes of 0.025 M phosphoric acid, previously adjusted with triethylamine to a pH of 3.0±0.1, and 13 volumes of acetonitrile. Make adjustments if necessary.
          Resolution solution Dissolve a quantity of Ciprofloxacin Ethylenediamine Analog RS in Standard preparation to obtain a solution containing 50 μg per ml.
          Standard preparation Dissolve an accurately weighed quantity of Ciprofloxacin Hydrochloride RS in Diluent to obtain a solution having a known concentration of about 200 μg per ml.
          Assay preparation Transfer 5 Ciprofloxacin Hydrochloride Tablets to a 500-ml volumetric flask, add 400 ml of Diluent and sonicate for 20 minutes. Dilute with Diluent to volume, mix and filter. Dilute an accurately measured volume of this solution with Diluent to obtain a solution containing about 200 μg of ciprofloxacin per ml.
          Chromatographic system The chromatographic procedure may be carried out using (a) a stainless steel column (25 cm × 4.6 mm) packed with octadecylsilane chemically bonded to porous silica or ceramic microparticles (3 to 10 μm) maintained at 30º±1º, (b) Mobile phase at a flow rate of about 1.5 ml per minute and (c) an ultraviolet photometer set at 278 nm.
          To determine the suitability of the chromatographic system, chromatograph Resolution solution, and record the peak responses as directed under Procedure: the retention time for ciprofloxacin is between 6.4 and 10.8 minutes, the relative retention times are about 0.7 for ciprofloxacin ethylenediamine analog and 1.0 for ciprofloxacin and the resolution factor between the ciprofloxacin ethylenediamine analog and ciprofloxacin peaks is not less than 6. Chromatograph Standard preparation, and record the peak responses as directed under Procedure: the symmetry factor for the ciprofloxacin peak is not more than 2.0 and the relative standard deviation for replicate injections is not more than 1.5 per cent.
          Procedure Separately inject equal volumes (about 10 μl) of Standard preparation and Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.
          Calculation Calculate the content of C₁₇H₁₈FN₃O₃ in the portion of the Tablets taken, using the declared content of C₁₇H₁₈FN₃O₃ in Ciprofloxacin Hydrochloride RS. Each mg of C₁₇H₁₈FN₃O₃ is equivalent to 1.1101 mg of C₁₇H₁₈FN₃O₃.HCl.

Other requirements Comply with the requirements described under “Tablets” (Appendix 1.16).