Stability of roxatidine acetate in parenteral nutrient solutions containing different amino acid injections

다국어 초록 (Multilingual Abstract)

The stability of roxatidine acetate was investigated when they are mixed with parenteral nutrient(PN) solutions containing different amino acid injections. Roxatidine acetate hydrochloride 75mg, which was constituted with 5 ml of 5% dextrose injection, was added to 500 ml of PN solutions, and stored at 4℃ in a refrigerator or 25℃ in a temperature-controlled water bath. At predetermined time, samples were assayed by stability-indicating HPLC method. The results indicated that the stability of roxatidine acetate was dependent on the amino acid sources and storage temperatures. The percent of initial concentration remaining was from 58.0±0.6 to 93.6±1.0% depending on the amino acid sources and storage temperatures. No precipitation or haze was observed in both mixtures over the entire study period even though yellow discoloration was formed in one mixture from 3 weeks after mixing. The pH variations of all test solutions were minimal, which ranged from 6.0 to 7.0.
Roxatidine acetate hydrochloride [N-(3-[3-(1-piperidinylmethyl)-phenoxy]-propyl)acetoxyacetamide hydrochloride] is a histamine H2-receptor antagonist used in the treatment of peptic ulcers and hypersecretory conditions. The drug is thought to exert its action by inhibiting gastric acid secretion. The inhibitory effect is reported to be six-fold more potent than cimetidine.
Some patients who receive parenteral nutrient(PN) solution may require concurrent administration of histamine H2-receptor antagonist for treatment of gastric hypersecretory conditions. Due to limited number of intravenous sites, it is valuable to reduce a second administration site by co-infusion. However, there have been no reports on the stability of roxatidine acetate hydrochloride when it is added to PN solution though data on other H2-receptor antagonists are available. Therefore, the purpose of this study was to evaluate the stability of roxatidine acetate hydrochloride when it is directly added to PN solutions containing different amino acid infusions for extended periods of storage.

목차 (Table of Contents)

• Abstract
• Methods
• Preparation of Mixtures.
• High-performance liqiud chromatography (HPLC).
• Data analysis.
• Results
• Conclusion
• References