Yellepeddi Venkata K
College of Pharmacy, Roseman University of Health Sciences, South Jordan, UT
Department of Pharmaceutics and Pharmaceutical Chemistry, University of Utah, Salt Lake City, UT
Am J Health Syst Pharm. 2018 Jan 1;75(1):e28-e35. doi: 10.2146/ajhp160531.
The stability of an extemporaneously prepared preservative-free prochlorperazine 5-mg/mL nasal spray was evaluated.
The preservative-free prochlorperazine nasal spray was prepared by adding 250 mg of prochlorperazine edisylate to 50 mL of citrate buffer in a low-density polyethylene nasal spray bottle. A stability-indicating high-performance liquid chromatography (HPLC) method was developed and validated using the major degradant prochlorperazine sulfoxide and by performing forced-degradation studies. For chemical stability studies, 3 100-μL samples of the preservative-free prochlorperazine from 5 nasal spray bottles stored at room temperature were collected at days 0, 20, 30, 45, and 60 and were assayed in triplicate using the stability-indicating HPLC method. Microbiological testing involved antimicrobial effectiveness testing based on () chapter 51 and quantitative microbiological enumeration of aerobic bacteria, yeasts, and mold based on chapter 61. Samples for microbiological testing were collected at days 0, 30, and 60.
The stability-indicating HPLC method clearly identified the degradation product prochlorperazine sulfoxide without interference from prochlorperazine. All tested solutions retained over 90% of the initial prochlorperazine concentration for the 60-day study period. There were no detectable changes in color, pH, and viscosity in any sample. There was no growth of bacteria, yeast, and mold for 60 days in all samples tested.
An extemporaneously prepared preservative-free nasal spray solution of prochlorperazine edisylate 5 mg/mL was physically, chemically, and microbiologically stable for 60 days when stored at room temperature in low-density polyethylene bottles.
评估临时配制的不含防腐剂的5毫克/毫升氯丙嗪鼻喷雾剂的稳定性。
通过将250毫克乙磺半胱氨酸氯丙嗪添加到低密度聚乙烯鼻喷雾剂瓶中的50毫升柠檬酸盐缓冲液中来制备不含防腐剂的氯丙嗪鼻喷雾剂。开发并验证了一种稳定性指示高效液相色谱（HPLC）方法，该方法使用主要降解产物氯丙嗪亚砜并进行强制降解研究。对于化学稳定性研究，在第0、20、30、45和60天从5个室温保存的鼻喷雾剂瓶中收集3个100微升不含防腐剂的氯丙嗪样品，并使用稳定性指示HPLC方法进行三次测定。微生物检测包括基于《美国药典》第51章的抗菌效力测试以及基于《美国药典》第61章的需氧菌、酵母菌和霉菌的定量微生物计数。在第0、30和60天收集用于微生物检测的样品。
稳定性指示HPLC方法清楚地鉴定出降解产物氯丙嗪亚砜，不受氯丙嗪的干扰。在为期60天的研究期间，所有测试溶液的初始氯丙嗪浓度均保留超过90%。任何样品的颜色、pH值和粘度均未检测到变化。所有测试样品在60天内均未检测到细菌、酵母菌和霉菌生长。
临时配制的5毫克/毫升乙磺半胱氨酸氯丙嗪不含防腐剂的鼻喷雾剂溶液，在室温下储存在低密度聚乙烯瓶中时，在物理、化学和微生物方面60天内稳定。
