Compatibility and stability of ketorolac tromethamine and morphine hydrochloride in 0.9% sodium chloride injection (original) (raw)

The Pain Clinic, 2007

Abstract

ABSTRACT Introduction: Ketorolac added to morphine solution as a convenient regimen for pain management is common in clinical practice in many centers. However, the analytical confirmation of the compatibility and stability of this combination has rarely been performed. This study examined the compatibility and stability of ketorolac tromethamine and morphine hydrochloride combined in 0.9% sodium chloride injection. Materials and methods: Ketorolac tromethamine and morphine hydrochloride were mixed together in 0.9% sodium chloride injection at pH 5–9 at a final concentration of 2 mg/ml for ketorolac and 1 mg/ml for morphine. In addition, 20 different ketorolac–morphine mixture solutions were prepared by combing various concentrations of each individual drug. The compatibility and stability of these solutions were studied using high performance liquid chromatography. Results: There was no significant loss of drug, neither ketorolac tromethamine nor morphine hydrochloride, with the ketorolac (2 mg/ml) + morphine (1 mg/ml) solution at pH 5–9 at room temperature over a period of 3 days. All solutions with a multiplication product of the initial ketorolac and morphine concentration (the [K] × [M] product) of ≤ 6.25 mg2/ml2 remained stable at room temperature over a period of 14 days. However, solutions with a [K] × [M] product ≥ 7.5 mg2/ml2 were stable for no more than 3 days. Conclusions: A ketorolac (2 mg/ml) + morphine (1 mg/ml) solution can be used at physiological pH and is stable for at least 3 days at room temperature. However, mixture solutions with a [K] × [M] product greater than 7.5 mg2/ml2 may not be suitable for use after a 3-day storage period because of poor drug compatibility and stability.

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