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1.4 CHEMICAL SCIENCES
The objective of the initial stages of this project was to develop a method for the separation of morphine sulphate and haloperidol using high performance liquid chromatography (HPLC). The HPLC methods were then validated. The validation parameters investigated were: accuracy, precision, linearity, specificity, system suitability, robustness, range. Method validation was carried out at the method development stage and throughout the project. Having successfully developed and validated the HPLC method for the separation of morphine sulphate and haloperidol it was then possible to continue to the next objective of the project i.e. to assess the chemical stability of the following: 1 Morphine sulphate in P.C.A. (Patient controlled Analgesia) silicone balloon infuser 2 Morphine sulphate in polypropylene syringes 3 Morphine sulphate (o.5-12 mg/ml) and haloperidol (o.25-2 ,g/L) in combination in polypropylene syringes Morphine sulphate (2 mg/l and 10mg/l) in P.C.A. infusers retained stability over the 40 days of testing (room temperature (22+-2°C) and 4°C). A 28 day shelf life has been allocated to morphine P.C.A.’s as a result of this work, and having taken into account microbiological validation of the compounding unit in St. James’s Hospital. P.C.A.’s are now available in batches in “ready-to-use” form for in-house, outside hospital use and home healthcare use. Morphine sulphate (2 mg/l and 10mg/l) in polypropylene syringes retained stability over the 30 days of testing (room temperature (22+-2°C) and 4°C). This project shows that it is feasible to conduct small-scale stability studies using HPLC within a hospital Pharmacy department with significant impact on clinical practice.
Lee, G.:Chemical Characterisations of Drug Stability. Masters Thesis. Dublin Institute of Technology, 2001.