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2010•Zhongguo yaofangRequires access

Quality Control for Azithromycin Sustained Release Suppository

Cheng Dong-sheng

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Abstract

OBJECTIVE:To establish the quality standard of azithromycin sustained release suppository.METHODS:TLC was applied for the identification of azithromycin and the content of azithromycin in the suppository was determined by HPLC.According to dissolution determination method stated in Chinese Pharmacopeia(2005 edition),accumulative dissolution of azithromycin sustained release suppository was determined using phosphate buffer as dissolution medium,and in vitro dissolution model was fitted.RESULTS:The identification method has a good specificity.The linear range of azithromycin was 50～800 μg·mL-(r= 1 0.999 8)with an average recovery of 100.56%(RSD1.84%,n=6).In vitro release model conformed with Higuchi equation.CONCLUSION:Established method is reliable,specific and accurate,drug release of suppository in vitro is in line with standard.

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What this paper is about

OBJECTIVE:To establish the quality standard of azithromycin sustained release suppository.METHODS:TLC was applied for the identification of azithromycin and the content of azithromycin in the suppository was determined by HPLC.According to dissolution determination method stated in Chinese Pharmacopeia(2005 edition),accumulative dissolution of azithromycin sustained release suppository was determined using phosphate buffer as dissolution medium,and in vitro dissolution model was fitted.RESULTS:The identification method has a good specificity.The linear range of azithromycin was 50～800 μg·mL-(r= 1 0.999 8)with an average recovery of 100.56%(RSD1.84%,n=6).In vitro release model conformed with Higuchi equation.CONCLUSION:Established method is reliable,specific and accurate,drug release of suppository in vitro is in line with standard.

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Available abstract

OBJECTIVE:To establish the quality standard of azithromycin sustained release suppository.METHODS:TLC was applied for the identification of azithromycin and the content of azithromycin in the suppository was determined by HPLC.According to dissolution determination method stated in Chinese Pharmacopeia(2005 edition),accumulative dissolution of azithromycin sustained release suppository was determined using phosphate buffer as dissolution medium,and in vitro dissolution model was fitted.RESULTS:The identification method has a good specificity.The linear range of azithromycin was 50～800 μg·mL-(r= 1 0.999 8)with an average recovery of 100.56%(RSD1.84%,n=6).In vitro release model conformed with Higuchi equation.CONCLUSION:Established method is reliable,specific and accurate,drug release of suppository in vitro is in line with standard.

Key concepts: Suppository, Azithromycin, Chromatography, Dissolution, Chemistry, Dissolution testing, Phosphate buffered saline, High-performance liquid chromatography

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