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《Tianjin Pharmacy》 2009-03
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Related substance test and assay of cefixime and assay of cefixime in tablets or capsules by HPLC

Du Xu1,Feng Yong2,Cao Xiaoyun1(1.Tianjin Institute of Drug Control,Tianjin 300070;2.Tianjin Port Hospital,Tianjin 300456)  
Objective: To establish an HPLC method for quantitative determination of amount of cefixime and related substances,and amount of cefixime in tablets or capsules.Method: Cefixime was separated on ODS column with mobile phase of tetrabutylammonium hydroxide solution-acetonitrile(70∶30) and detected at 254 nm.Results: The standard curve was linear within the range of 0.06~0.30 mg/ml and the correlation coefficient was 0.999 9.The precision of cefixime was good(RSD was 0.7%,n=9) with the lowest detectable limit of 0.03 μg(S/N3).The average recovery of cefixime from its tablet and capsule was 99.5%(RSD was 0.5%,n=9) and 99.8%(RSD was 0.3%,n=9) respectively.Conclusion: the proposed method is simple,rapid,accurate and reliable.
【CateGory Index】: R927.11
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