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.

Objective To evaluate the impact of chemotherapy compliance on the therapeutic efficacy of induction chemotherapy plus concurrent chemoradiotherapy versus induction chemotherapy plus radiotherapy alone for patients with locally advanced nasopharyngeal carcinoma (NPC). Methods Based on intention to treat analysis (ITT) for 400 patients, 314 patients were analyzed by per protocol (PP) analysis. The patients were divided into induction chemotherapy plus concurrent chemoradiotherapy group (IC/CCRT, 127 patients) or induction chemotherapy plus radiotherapy group (IC/RT, 187 patients). The patients who completed 2 cycles of induction chemotherapy and at least 2 cycles of concurrent chemotherapy in the IC/CCRT group and the patients who completed 2 cycles of induction chemotherapy in the IC/RT group were analyzed. Radiotherapy was given by two-dimensional technique with γ-ray, X-ray and electron beams. The chemotherapy regimen was FUDR plus carboplatin for induction chemotherapy and carboplatin alone for concurrent chemotherapy. Results The follow-up rate was 96.2%. 295 patients were followed to at 3 years. Based on PP analysis, Grade 3/4 toxicity was found in 23.6% of the patients in IC/CCRT group and 13.4% in the IC/RT group (χ~2 =5,50,P=0.019). No grade 4 toxicity was found in the IC/RT group. The median follow-up time was 3.9 years, and no significant difference was found between the two groups in 3-year overall survival (78.1% : 84.6% ;χ~2 = 0. 61, P =0. 435), disease-free survival (74.3 % : 70.1% ;χ~2= 0. 12, P= 0.731), Iocoregional relapse-free survival (89.7% : 89.5% ; χ~2= 0. 10, P= 0.748), or distant metastasis-free survival (78.9%:76.5% ;χ~2=0.05,P=0.825). Conclusions With more severe toxicities, the IC/CCRT regimen does not improve the overall survival in locally advanced NPC patients compared with the IC/RT regimen.