Stability of dobutamine 500 mg in 50 ml syringes prepared using a Central Intravenous Additive Service

Patel, N. ORCID: https://orcid.org/0000-0002-8600-0663, Taki, M., Tunstell, P., Forsey, P. and Forbes, B. (2012) Stability of dobutamine 500 mg in 50 ml syringes prepared using a Central Intravenous Additive Service. European Journal of Hospital Pharmacy, 19 (1). pp. 52-56. ISSN 2047-9956 doi: 10.1136/ejhpharm-2011-000027

Abstract/Summary

Objectives A pharmacy Central Intravenous Additives Service (CIVAS) provides ready to use injectable medicines. However, manipulation of a licensed injectable medicine may significantly alter the stability of drug(s) in the final product. The aim of this study was to develop a stability indicating assay for CIVAS produced dobutamine 500 mg in 50 ml dextrose 1% (w/v) prefilled syringes, and to allocate a suitable shelf life. Methods A stability indicating high performance liquid chromatography (HPLC) assay was established for dobutamine. The stability of dobutamine prefilled syringes was evaluated under storage conditions of 4°C (protected from light), room temperature (protected from light), room temperature (exposed to light) and 40°C (protected from light) at various time points (up to 42 days). Results An HPLC method employing a Hypersil column, mobile phase (pH=4.0) consisting of 82:12:6 (v/v/v) 0.05 M KH2PO4:acetonitrile:methanol plus 0.3% (v/v) triethylamine with UV detection at λ=280 nm was specific for dobutamine. Under different storage conditions only samples stored at 40°C showed greater than 5% degradation (5.08%) at 42 days and had the shortest T95% based on this criterion (44.6 days compared with 111.4 days for 4°C). Exposure to light also reduced dobutamine stability. Discolouration on storage was the limiting factor in shelf life allocation, even when dobutamine remained within 5% of the initial concentration. Conclusions A stability indicating HPLC assay for dobutamine was developed. The shelf life recommended for the CIVAS product was 42 days at 4°C and 35 days at room temperature when protected from light.

Item Type	Article
URI	https://reading-clone.eprints-hosting.org/id/eprint/37513
Identification Number/DOI	10.1136/ejhpharm-2011-000027
Refereed	Yes
Divisions	No Reading authors. Back catalogue items
Publisher	BMJ
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