Determination of Impurities Including Polymers in Latamoxef Sodium by HPSEC / 中国药师

ABSTRACT

Objective:To establish a high performance size-exclusion chromatography ( HPSEC) method for the determination of impurities including polymers in latamoxef sodium. Methods:The analysis was performed on a Zenix SEC-150 column(7. 8 mm × 300 mm, 3 μm)with the mobile phase of 0. 005 mol·L-1 phosphate buffer solution [0. 005 mol·L-1 disodium hydrogen phosphate-0. 005 mol·L-1 sodium dihydrogen phosphate (61∶39), pH 7. 0] at a flow rate of 0. 8 ml·min-1. The detection wavelength was set at 254 nm. The column tempretrue was 25℃ and the injection volume was 10μl. Results:The impurities including polymers in latamoxef so-dium were completely separated from latamoxef. The linear range of latamoxef was 0. 98-97. 73 μg·ml-1(r=0. 999 9). The limit of quantitation of latamoxef was 2. 9 ng, and the detection limit was 1. 0 ng. The linear range of the total impurities was 0. 45-2. 8 mg· ml-1(r=0. 999 5). Conclusion: The established method is accurate, rapid and reproducible, and suitable for the determination of impurities including polymers in latamoxef sodium.