Gupta Vishnu Das
Pharmaceutics Division, University of Houston, Houston, TX.
Int J Pharm Compd. 2002 Jul-Aug;6(4):316-7.
The stability of ketamine hydrochloride (10mg/mL) in water for injection stored in polypropylene syringes has been studied at 25 deg C by means of a stability-indicating high-performance liquid chromatographic assay method. The concentrations of the drug were directly related to peak heights, and the percent relative standard deviation based on five injections was 1.9. The drug decomposed only when the solution was boiled after sodium hydroxide was added. It did not decompose in the presence of an acid or after 30 minutes of boiling. The injection did not lose potency after 30 days of storage at 25 deg C, and the pH value of 4.2 did not change. Ketamine hydrochloride appears to be a very stable drug.
采用一种稳定性指示高效液相色谱测定法,在25℃下研究了储存在聚丙烯注射器中的注射用水中盐酸氯胺酮(10mg/mL)的稳定性。药物浓度与峰高直接相关,基于五次进样的相对标准偏差百分比为1.9。仅在加入氢氧化钠后将溶液煮沸时药物才会分解。在有酸存在的情况下或煮沸30分钟后它不会分解。在25℃储存30天后该注射液没有失去效力,且pH值4.2没有变化。盐酸氯胺酮似乎是一种非常稳定的药物。