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LC/MS Determination of Ceftriaxone Sodium Related Substances

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To develop a capillary electrophoresis method for determination of related substances in ceftriaxone sodium.MethodsThe uncoated fused-silica capillary (50 cm×75 μm) was used.The running buffer composed of 40 mmol·L-1 phosphate buffer containing 100 mmol·L-1 sodium dodecylsulphate.The separation voltage was 12 kV (40-50 μA) and the capillary temperature was 25 .The detection wavelength was 254 nm.The sample was solved in water with a concentration of 5 mg·mL-1 and 0.1 mg·mL-1 respectively for impurity determination and content assay,and was injected to the column by pressure(3.447 kPa) for 4 s. Results:Twenty-one impurities in ceftriaxone sodium could be detected.Ceftriaxone sodium and the degradations obtained by acid hydrolysisalkaline hydrolysis and oxidation could be separated well.The calibration curve of ceftriaxone sodium was linear in the range of 0.0125-0.4 mg·mL-1.The limit of detection and limit of quantitation were 5.2 μg·mL-1 and 12.5 μg·mL-1respectively.The number of impurities detected by CE was more than that by HPLChowever the biggest impurity content determined by CE was the same as that by HPLC.The values of intra-day and inter-day RSD of migration time of impurities were less than 0.94% and 1.15% respectively.The values of intra-day and inter-day RSD of peak area were less than 17.0% and 26.8% respectively.The lower impurity content wasthe bigger the RSD was.Conclusions:The HPCE method developed was accurateand could be complement to HPLC for determination of the impurity and help pharmaceutical manufacturer to analysis the possible source of the impurity.

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Keywords: capillary electrophoresis; ceftriaxone sodium; quality control; related substance

Document Type: Research Article

Publication date: 01 March 2005

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  • Journal of Pharmaceutical Analysis is a professional journal administrated by China Association for Science and Technology, sponsored by Chinese Pharmaceutical Association, held by National Institutes for Food and Drug Control, edited and published by the Editorial Board of Journal of Pharmaceutical Analysis, and publicly distributed at home and abroad. It is one of the first group of journals that created by academic leaders in the field of drug control. It originated from Drug Control Communication which magazine was founded in 1951 and later been renamed in 1981. In 2005, it was changed from bi-monthly journal to monthly journal. Journal of Pharmaceutical Analysis is among core journals in nature sciences and even other Chinese core journals, whose main columns are research reports, communications, review, forum, information and etc. It mainly reports the latest research results, explore new theories, introduce new development, spread new techniques, and promote new methods of pharmaceutical analysis. Its contents include peer-reviewed research reports, research presentation and summary reviews on all aspects of pharmaceutical analysis including drug development, pharmaceutical manufacturing, clinical research, drug safety, quality assessment, and market surveillance. Main authors and target reader are professional and technical personnel engaged in research, application as well as higher education in pharmaceutical analysis.
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