Dissolution curve methodology validation of cefixime granules
Pages: 373-376
Year: 2017 Issue: 5
Journal: Chinese Journal of Antibiotics
Abstract: Objective To establish a measuring method of the dissolution curve of cefixime granules.Methods Referring to the dissolution detection method of cefixime granules,the dissolution of cefixime granules was measured by HPLC.The chromatographic condition is the following:the octadecyl silane bonded silica as the filler (Kromasil C18,250mm×4.6mm,5μm),the tetra-n-butyl ammonium hydroxide solution-acetonitrile (72:28) as the mobile phase,the detection wavelength of 254nm and the column temperature 30℃.The dissolution conditions involves a phosphate buffer solution at pH of 7.2,the Slurry method of 50r/min and the dissolution sampling time of 5,10,15,30 and 45min.Through the experimental studies of the linearity and scope,the solution stability,the precision test,the repeatability and recovery test and etc.,the dissolution method of cefixime granules was validated.Results The results of the dissolution verification methodology were good.There was a good linear relationship when the cefixime concentration was from 0.48 to 477.84g/mL.Linear equation was:Y=41.08X-10.231.The test solution was basically stable with in 10h.Conclusion The method can accurately determine the dissolution of cefixime granules.
Year: 2017 Issue: 5
Journal: Chinese Journal of Antibiotics
Abstract: Objective To establish a measuring method of the dissolution curve of cefixime granules.Methods Referring to the dissolution detection method of cefixime granules,the dissolution of cefixime granules was measured by HPLC.The chromatographic condition is the following:the octadecyl silane bonded silica as the filler (Kromasil C18,250mm×4.6mm,5μm),the tetra-n-butyl ammonium hydroxide solution-acetonitrile (72:28) as the mobile phase,the detection wavelength of 254nm and the column temperature 30℃.The dissolution conditions involves a phosphate buffer solution at pH of 7.2,the Slurry method of 50r/min and the dissolution sampling time of 5,10,15,30 and 45min.Through the experimental studies of the linearity and scope,the solution stability,the precision test,the repeatability and recovery test and etc.,the dissolution method of cefixime granules was validated.Results The results of the dissolution verification methodology were good.There was a good linear relationship when the cefixime concentration was from 0.48 to 477.84g/mL.Linear equation was:Y=41.08X-10.231.The test solution was basically stable with in 10h.Conclusion The method can accurately determine the dissolution of cefixime granules.
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