Chemical stability of a solution of bupivacaine hydrochloride 0.125% and sufentanil citrate 0.5 μg/mL

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Chemical stability of a solution of bupivacaine hydrochloride 0.125% and sufentanil citrate 0.5 μg/mL for filling syringes using a repeater pump

Karin Janssen, PharmD; René Wisselo, B App Sci; Charles Geerlings, PharmD; Jan Pieter Schouten, PharmD, MBM

ABSTRACT: Study objective: In Sint Franciscus Gasthuis, Rotterdam, The Netherlands, syringes filled with bupivacaine hydrochloride 0.125% and sufentanil citrate 0.5 μg/mL are administered epidurally during post-operative analgesia. These syringes are filled in the pharmacy using a Baxa Repeater pump. The suitability of the filling method and the shelf-life of the solution in the syringes were investigated.

Methods: During the filling process six samples were taken. Three syringes were stored at room temperature and three in the refrigerator. Samples were taken on days 4, 7, 14 and 28. High performance liquid chromatographic (HPLC) methods were used to measure the concentrations of both drugs in the samples.

Results: No loss of drugs was observed during the filling process. After 28 days at room temperature and in the refrigerator, the concentration of bupivacaine hydrochloride was 97.4 ± 0.9% and 97.9 ± 1.0% respectively, and that of sufentanil
citrate was 95.6 ± 4.2% and 99.2 ± 1.4%.

Conclusion: The filling method used with a Baxa Repeater pump is acceptable. Bupivacaine/sufentanil solution in syringes is chemically stable for at least 28 days in the refrigerator.

References: EJHP Science • Volume 15 • 2009 • Issue 1 • P. 11-14