OBJECTIVE To establish a high performance size exclusion chromatography （HPSEC） method for the determination of high molecular weight impurities in cefadroxil capsules. METHODS A TSK-GEL G2000S WXL column （30 cm×7.8 mm×5 μm） was used with the mobile phase consisting of 0.005 mol·L-1 ammonium acetate solution （adjust to pH of 7.0 with diluted ammonia solution） at a flow rate of 0.7 mL·min-1，and the detection wavelength was 263 nm. RESULTS The calibration curves for high molecular weight impurities were linear in the range of 0.035-5.00 mg·mL of cefadroxil （r=0.999 9）. The limit of detection for cefadroxil was 1.5 ng，and the limit of quantitation for high molecular weight impurities calculated as cefadroxil was 4.9 ng. The RSD for replicate injections of reference solution （n=6） was 0.24%，and the repeatability for 6 measurements was 1.35%. CONCLUSION The HPSEC method is simple，specific and sensitive.
WNG Cheng-gng;WNG Jun-qiu;ZHNG Zhe;ZHOU Li-chun;YU Li.
Determination of High Molecular Weight Impurities in Cefadroxil Capsules by HPSEC[J]. Chinese Pharmaceutical Journal, 2011, 46(13): 1027-1029
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