注射用盐酸头孢吡肟与3种输液配伍的高分子杂质研究

摘要

目的：采用高效液相色谱法研究注射用盐酸头孢吡肟与3种常用输液配伍后高分子杂质的稳定性。方法建立注射用盐酸头孢吡肟在3种输液的配伍稳定性中的高分子杂质测定方法，分析混合液6 h 内高分子杂质的稳定性。用葡聚糖凝胶 g －10为填料，以 pH =7.0的0.1 mol / L 磷酸盐缓冲液为流动相 A，以水为流动相 B，流速为每分钟0.6 mL，检测波长为254 nm。结果在室温30℃条件下，注射用盐酸头孢吡肟在3种配伍液中2 h 内基本稳定，且与0.9%氯化钠注射液配伍时高分子杂质在6 h 内基本稳定。结论注射用盐酸头孢吡肟最好与0.9%氯化钠注射液配伍使用。%Objective To adopt the HPLC method for investigating the stability of high molecular weight impurities between Cefepime Hydrochloride Injection with the three kinds of common used infusion in clinic. Methods The HPLC method for the determination of high molecular weight impurities in the miXed solutions of Cefepime Hydrochloride Injection and three kinds of infusion was estab-lished. The stability of high molecular weight impurities in the miXed solution were assayed within 6 h. With sephadeX g - 10 as the filling material, 0. 1 mol / L phosphate buffer solution (pH = 7. 0) as the mobile phase A and water as the mobile phase B, the detection was performed at the flow rate of 0. 6 mL / min and the detection wavelength of 254 nm. Results Under the room temperature 30 ℃ , Cefepime Hydrochloride Injection in 3 kinds of compatibility solution was basically stable within 2 h, moreover the high molecular weight impurities in its compatibility solution with sodium chloride solution were basically stable within 6 h. Conclusion Cefepime Hydrochlo-ride Injection should be best used as the compatibility with 0. 9% sodium chloride solution.