Stability of tramadol hydrochloride with fentanyl citrate in 0.9% sodium chloride injection

FANG Baoxia; CHEN Fuchao; LI Chunlei; LIU Huimin; ZHU Xuesong

doi:10.3969/j.issn.1006-0111.2014.05.008

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Objective To study the stability of tramadol hydrochloride with fentanyl citrate in 0.9% sodium chloride injection. Methods The changes in appearance and pH value of the mixture of the two injections in 0.9% sodium chloride injection within 72 hours at ambient temperature were observed. The concentrations of the two drugs were determined by HPLC. The chromatographic separation was achieved on SinoChrom ODS-BP column, and the mobile phase consisted of acetonitrile:0.05 mol/L potassium dihydrogen phosphate (25:75) at a flow rate of 1.0 ml/min.. Results No significant differences were found in the pH value and appearance of the solution. The contents of tramadol hydrochloride and fentanyl citrate were high than 98% within 72 hours. Conclusion The mixture of tramadol hydrochloride with fentanyl citrate in 0.9% sodium chloride injection was stability within 72 hours under room temperature.

Stability of tramadol hydrochloride with fentanyl citrate in 0.9% sodium chloride injection

Department of Pharmacy, Dongfeng Hospital Affiliated to Hubei University of Medicine, Shiyan 442008, China

Received Date: 2013-01-19

Rev Recd Date: 2013-04-10

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Abstract: Objective To study the stability of tramadol hydrochloride with fentanyl citrate in 0.9% sodium chloride injection. Methods The changes in appearance and pH value of the mixture of the two injections in 0.9% sodium chloride injection within 72 hours at ambient temperature were observed. The concentrations of the two drugs were determined by HPLC. The chromatographic separation was achieved on SinoChrom ODS-BP column, and the mobile phase consisted of acetonitrile:0.05 mol/L potassium dihydrogen phosphate (25:75) at a flow rate of 1.0 ml/min.. Results No significant differences were found in the pH value and appearance of the solution. The contents of tramadol hydrochloride and fentanyl citrate were high than 98% within 72 hours. Conclusion The mixture of tramadol hydrochloride with fentanyl citrate in 0.9% sodium chloride injection was stability within 72 hours under room temperature.

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Stability of tramadol hydrochloride with fentanyl citrate in 0.9% sodium chloride injection

doi: 10.3969/j.issn.1006-0111.2014.05.008

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通讯作者: 陈斌, [email protected]

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