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Stability of dobutamine 500 mg in 50 ml syringes prepared using a Central Intravenous Additive Service
  1. Nilesh Patel1,
  2. Mohammed Taki2,
  3. Paul Tunstell3,
  4. Paul Forsey3,
  5. Ben Forbes2
  1. 1Department of Pharmacy, Kingston University, Kingston upon Thames, UK
  2. 2Institute of Pharmaceutical Science, King's College London, London, UK
  3. 3King's Health Partners, Guy's and St Thomas' NHS Foundation Trust, London, UK
  1. Correspondence to Mr P Tunstell, Guy's and St Thomas' NHS Foundation Trust, King's Health Partners, London, SE1 9RT, UK; paul.tunstell{at}gstt.nhs.uk

Abstract

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.

This paper is freely available online under the BMJ Journals unlocked scheme, see http://ejhp.bmj.com/info/unlocked.dtl

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