Determination of Content and Related Substances of Cefetamet Pivoxil Hydrochloride Tablets by HPLC / 中国药师

ABSTRACT

Objective:To establish an HPLC method to determine the content and related substances of cefetamet pivoxil hydro-chloride tablets. Methods:A Hypersil ODS2 C18 (250 mm × 4. 6 mm,5 μm) column was used. The mobile phase was 0. 005 mol· L-1 tetrabutylammonium hydroxide solution-acetonitrile (64: 36, adjusting pH to 4. 5 with phosphoric acid). The flow rate was 1. 0 ml·min-1 . The detection wavelength was 232 nm. The column temperature was 30℃ and the injection volume was 10 μl. Results:Cefetamet was completely separated from the related substances. The equation of linear regression was Y=2.29 ×104X-4.30 ×104(r=0. 999 9) and the linear range of cefetamet was 51. 01-510. 07 μg·ml-1 . The average recovery was 99. 60% and RSD was 0. 84%(n=9). Conclusion:The method is simple, accurate and suitable. It can be used for the determination of content and related sub-stances of cefetamet pivoxil hydrochloride tablets.