摘要
目的研究盐酸恩丹西酮口服液的制备及质量控制方法,考察其稳定性并预测室温贮存有效期。方法确定了盐酸恩丹西酮口服液的处方,应用紫外分光光度法测定口服液中盐酸恩丹西酮的含量,用初均速法预测有效期。结果盐酸恩丹西酮口服液质量浓度在4.236～21.18μg/mL范围内与吸光度线性关系良好,低、中、高3种质量浓度样品的回收率分别为100.74%,103.56%,102.86%,日内和日间精密度均较好;在室温(20℃)下,盐酸恩丹西酮口服液有效期为1.5年。结论该制剂制备工艺简单,质量易于控制,稳定性较好。
Objective To study the preparing method and quality control for Ondansetron Hydrochloride Oral Solution,to investigate its stability and to predict the period of validity under the room temperature.Methods The prescription of Ondansetron Hydrochloride Oral Solution was established.The content and recovery rate of ondansetron hydrochloride were determined by UV-spectrophotometry and the stability was detected by the initial average rate method.Results Ondansetron Hydrochloride Oral Solution was prepared,which showed good linearity over the range of 4.236-21.18 μg/mL.The recovery rates in the samples with low,middle and high concentrations were 100.74%,103.56%,102.86%respectively.The intra-day and inter-day RSD were quite well.Under the room temperature,the storage life of Ondansetron Hydrochloride Oral Solution was 18 months.Conclusion The preparation technology is simple with easily controllable quality and good stability.
出处
《中国药业》
CAS
2011年第1期40-42,共3页
China Pharmaceuticals
关键词
盐酸恩丹西酮
制备
质量控制
稳定性
ondansetron hydrochloride
preparation
quality control
stability
