A fully validated HPLC-UV detection method associated with color variation control for the evaluation of the long term stability of calcium levofolinate solutions in polyolefin infusion bags and in polypropylene syringes in dose banding conditions
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View abstract on PubMed
Summary
This summary is machine-generated.This study confirms the long-term stability of calcium levofolinate in infusion bags and syringes for up to 20 weeks. A validated HPLC method supports centralized production of this essential medication.
Area Of Science
- Pharmaceutical Sciences
- Analytical Chemistry
- Drug Stability
Background
- Calcium levofolinate is a critical medication requiring stable storage conditions.
- Standardized dosing, or dose banding, necessitates reliable stability data for various pharmaceutical containers.
- Assessing long-term stability in polyolefin infusion bags and polypropylene syringes is crucial for clinical use.
Purpose Of The Study
- To develop and validate a high-performance liquid chromatography (HPLC) stability-indicating assay.
- To evaluate the long-term stability of calcium levofolinate at standardized doses.
- To assess stability in polyolefin (POF) infusion bags and polypropylene syringes.
Main Methods
- Aseptic preparation of diluted calcium levofolinate solutions in POF bags and polypropylene syringes.
- Storage under refrigeration (5°C ± 3°C) in the dark.
- Evaluation of microbiological, physical, and chemical stability using a validated HPLC method.
Main Results
- Calcium levofolinate stability confirmed for 15-19 weeks in POF bags at doses of 160-400 mg.
- Stability confirmed for 20 weeks in polypropylene syringes at a 25 mg dose.
- All microbiological tests were negative, indicating product integrity.
Conclusions
- A simple, accurate, and stability-indicating HPLC method was successfully developed and validated.
- The study supports the centralized production of calcium levofolinate under the investigated conditions.
- Findings validate the use of POF bags and polypropylene syringes for storing calcium levofolinate at specified doses.
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