Stability of cefazolin sodium and metronidazole at 8 degrees C for use as an i.v. admixture.

T E Rivers, H A McBride, J M Trang
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Abstract

The stability of cefazolin 1 g in metronidazole 500 mg/100 mL at 8 degrees C was studied for use as an IV admixture. The commercially available injection of cefazolin sodium 1 g vial was diluted to 5 mL with 0.9% sodium chloride injection and added to metronidazole 500 mg/100 mL. Following dilution of 2 mL to 100 mL with water, 1-mL aliquots were transferred to glass vials, refrigerated at 8 degrees, and assayed for cefazolin and metronidazole concentration at 0, 1, 2, 4, 8, 12, 24, 36, 48, and 72 hours after preparation. The concentration of cefazolin and metronidazole was determined by a stability-indicating high-performance liquid chromatographic method. The range of concentration was determined to be within 5% of the 0-hour mean concentration. Over the 72-hour period, the mean concentration of cefazolin at all assay times was within 98.4 to 101.0% of the initial concentration. The mean concentration of metronidazole at each assay time was 96.9 to 104.9% of the initial concentration. Cefazolin sodium 10 mg/mL and metronidazole 5 mg/mL, prepared by adding reconstituted cefazolin to a glass bottle of metronidazole ready-to-use solution, were stable for 72 hours when stored at 8 degrees C.

头孢唑林钠和甲硝唑在8℃静脉注射时的稳定性。
研究了头孢唑林1 g在甲硝唑500 mg/100 mL溶液中作为静脉注射剂在8℃下的稳定性。将市售头孢唑林钠注射液1 g瓶用0.9%氯化钠注射液稀释至5 mL,加入甲硝唑500 mg/100 mL。用水将2 mL稀释至100 mL后,将1 mL等分装移入玻璃瓶,8℃冷藏,于配制后0、1、2、4、8、12、24、36、48、72小时测定头孢唑林和甲硝唑的浓度。采用稳定性指示高效液相色谱法测定头孢唑林和甲硝唑的浓度。确定浓度范围在0小时平均浓度的5%以内。72小时内,头孢唑啉的平均浓度在初始浓度的98.4% ~ 101.0%之间。每次测定时甲硝唑的平均浓度为初始浓度的96.9 ~ 104.9%。将重组头孢唑林加入甲硝唑即食溶液的玻璃瓶中,制备头孢唑林钠10 mg/mL和甲硝唑5 mg/mL,在8℃下保存72小时稳定。
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