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Ofloxacin Tablets Yangfushaxing Pian Ofloxacin Tablets This product containing ofloxacin (C18H20FN3O4) should be marked volume 90.0% ~ 110.0%. 【Characters】 This product is white or slightly yellow plates or薄膜衣片, after removal of coating significantly to yellowish white. 】 【Identification (1) under the HPLC chromatogram recorded in the main peak for the sample solution should be consistent with the retention time of reference substance solution of the main peak of retention time consistent. (2) check the appropriate fine chemicals, and 0.1mol / L hydrochloric acid dissolved and diluted into 1ml of each solution containing ofloxacin 6μg, filtration, the filtrate according to ultraviolet - visible spectrophotometry (Appendix Ⅳ A ) measured in the 294nm wavelength of maximum absorption. 】 【Check determination of the material taken for examination under reserve liquid products as a solution for the test materials; precise amount of check amount plus 0.1mol / L hydrochloric acid diluted 6μg each containing 1ml of the solution, as control solution. According to ofloxacin under related substances detected for the sample if any impurities chromatogram peaks may not be a single impurity peak area peak area is greater than the control solution (0.5%), the impurity peak areas and (no small the main peak in the control solution of 0.05 times the area of the peak is negligible) should be no larger than the main peak area of the control solution of 2-fold (1.0%). Dissolution check the goods, according to dissolution test method (first method appendix Ⅹ C) to hydrochloric acid (9 → 1000) 900ml for the dissolution medium speed for 50 minutes to each, according to the operation, after 30 minutes, the check solution amount of filtration, the filtrate added precision check volume 2ml, buy 50ml量瓶, add diluted to scale dissolution medium, shaken, according to ultraviolet - visible spectrophotometry (Appendix Ⅳ A), in the determination of wavelength of 294nm absorbance ; another reference substance ofloxacin check amount that will be fine, plus the dissolution medium and dissolved in dilute 1ml into each containing 4.5μg about the solution, the same method to calculate the volume of each of the dissolution. Limit of 80% mark should be in order. Other should be consistent with the tablet under the provisions of the relevant (Appendix Ⅰ A). 【照】 HPLC high-performance liquid chromatography (Appendix Ⅴ D) Determination. Chromatographic conditions and system suitability test octadecyl silane bonded silica as the filler; to high sodium chlorate ammonium acetate solution (from ammonium acetate and 4.0g sodium 7.0g, adding water to make 1300 dissolved with phosphoric acid to adjust pH value of 2.2) - acetonitrile (85:15) as mobile phase; the detection wavelength was 294nm. Ofloxacin check amount, and 0.1mol / L hydrochloric acid and dissolved in dilute 1ml made about each of the solution containing 1mg, buy ultra-violet light (254nm) irradiation of more than four hours, check into the liquid chromatograph 10μl theoretical plate number calculated by the ofloxacin peak of not less than 5000, close to the pre-peak ofloxacin and ofloxacin peak impurity peak separation should meet the requirement. Assay from 10 of the goods, precision that is scheduled to study a small amount of precision that check (about the equivalent of ofloxacin 0.1g), buy 100ml量瓶, the increase in 0.1mol / L hydrochloric acid dissolved and diluted to calibration, shake, filter, filtrate as continued access for goods store test fluid, the volume of check-precision 5ml, buy 50ml量瓶, the increase in 0.1mol / L hydrochloric acid solution to scale, shake, precision volume of 10μl were taken into the liquid chromatography to record chromatograms; another reference substance ofloxacin check amount that will be fine with 0.1mol / L hydrochloric acid and dissolved into quantitative dilution 1ml of each solution containing 0.12mg of ofloxacin with determination of by external standard method with peak area, that is too. 【Category】 with ofloxacin. 【Specification】 0.1g 【Storage】 shading, sealing preservation