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Stability and compatibility of admixtures containing bupivacaine hydrochloride and ketorolac tromethamine for parenteral use
  1. Hani Abdeltawab1,
  2. Jagdish Kumar Jaiswal2,
  3. Simon W Young3,
  4. Darren Svirskis1,
  5. Andrew Hill4,
  6. Manisha Sharma1
  1. 1School of Pharmacy, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand
  2. 2Auckland Cancer Society Research Centre, Faculty of Medical & Health Sciences, and Maurice Wilkins Centre for Molecular Biodiscovery, The University of Auckland, Auckland, New Zealand
  3. 3School of Medicine, Faculty of Medical and Health sciences, The University of Auckland, Orthopedic Consultant, North Shore Hospital, Auckland, New Zealand
  4. 4Department of Surgery, School of Medicine, Faculty of Medical & Health Sciences, The University of Auckland, Middlemore Hospital, Auckland, New Zealand
  1. Correspondence to Dr Manisha Sharma, School of Pharmacy, The University of Auckland Faculty of Medical and Health Sciences, Auckland 1142, New Zealand; manisha.sharma{at}auckland.ac.nz

Abstract

Objective Bupivacaine hydrochloride (BH) and ketorolac tromethamine (KT) are commonly used in parenteral admixtures to manage postoperative pain. However, stability and compatibility data for these admixtures applicable to current practice are limited, posing the patient to potential risk.

Methods The stability of BH/KT admixtures in commonly used parenteral fluids was studied in Eppendorf tubes and glass vials at ambient room temperature using a newly developed and validated stability-indicating high-performance liquid chromatography (HPLC) method capable of the simultaneous quantification of both drugs. The chemical compatibility of BH/KT was assessed using Fourier transform infrared spectroscopy (FTIR) and thermal analysis. Additionally, the validity of the developed HPLC method for the quantification of BH/KT in human plasma was evaluated.

Results BH and KT demonstrated <10% loss of their initial concentrations when prepared in Ringer, normal saline or dextrose solution at ambient temperature for up to 4 weeks. FTIR and thermal analysis demonstrated mild intermolecular interactions between BH and KT in solution, with no evidence of incompatibility. The developed HPLC method demonstrated satisfactory accuracy and precision for the simultaneous quantification of BH and KT in human plasma over the range of 0.2–3.2 µg·mL-1.

Conclusion BH/KT parenteral admixtures are chemically stable for a period of 4 weeks when stored at room temperature. The stability-indicating HPLC method is valid for BH/KT simultaneous determination in human plasma, facilitating pharmacokinetics studies.

  • anaesthesia and analgesia
  • drug incompatibility
  • analytic sample preparation methods
  • chemistry
  • pharmaceutical
  • drug compounding
  • pharmaceutical preparations

Data availability statement

All data relevant to the study are included in the article or uploaded as supplemental information.

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Data availability statement

All data relevant to the study are included in the article or uploaded as supplemental information.

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