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出 处:《今日药学》2010年第4期29-30,共2页Pharmacy Today
摘 要:目的建立同时测定注射用头孢他啶(含精氨酸)中头孢他啶和精氨酸的含量的质量控制方法。方法采用C18柱,0.01mol/L戊烷磺酸钠(用冰醋酸调节pH值至3.4,40%氢氧化钾溶液调节pH值至4.0):甲醇(85:15)为流动相,检测波长206/lm。结果头孢他啶在100.47~301.41μg/ml范围内,精氨酸在40.11~100.28μg/ml范围内线性关系良好,r值分别为0.9999与1,平均回收率分别为100.0%,99.3%,相对标准偏差值(RSD)分别为0.6%与0.5%。结论该法操作简单,结果准确,可用于以精氨酸为助溶剂的注射用头孢他啶的质量控制。Objective To establish a quality control method for the simultaneous determination of ceftazidime and arginine in ceftazidime for injection. Methods The C18 column was used, with a mobile phase of 0.01 mol/L sodium pentanesulfonate and methanol (85:15 ), and the detection wavelength was 206 nm. Results The linear ranges of ceftazidime and arginine were 100.47 -301.41μg/ml and d0.11 -100.28μg/ml, respectively. The average recoveries were 100.0% for ceftazidime, and 99.3% for arginine. RSD were 0.6% for ceftazidime, and 0.5% for arginine. Conclusion The method is convenient, accurate, and can be used for the quality control of ceftazidime for injection.
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