摘要
目的采用渗透压摩尔浓度法快速测定注射用丙戊酸钠的含量。方法取本品1支,用水稀释成浓度约为20 mg·mL^(-1)的溶液,测定其渗透压摩尔浓度后,计算含量。结果本方法重复性RSD为0.82%,高、中、低浓度的平均回收率分别为100.1%、99.5%、99.8%(n=3),用15批样品进行外部验证,外部验证平均绝对偏差为-0.8%,平均相对偏差为2.0%。结论该法快速、简便,可用于注射用丙戊酸钠生产过程的质量控制。
Objective To rapidly determine sodium valproate for injection with osmolality.Methods One sodium valproate injection was dilluted water to 20 mg·mL-1,and the osmolality was detected to measure the content.Results RSD of repeatability was 0.82%.Average recovery of high,middle,and low dose sodium valproate was 100.1%,99.5%,and 99.8%(n=3),respectively.Fifteen sample were detected,The average absolute difference of prediction for test was-0.8%,and the mean relative difference of prediction for test was 2.0%.Conclusion The method is rapid and simple,and meets the quality control requirement of production process.
作者
张迪
黄海
张丽
岳青阳
徐万魁
ZHANG Di;HUANG Hai;ZHANG Li;YUE Qing-yang;XU Wan-kui(Liaoning Institute for Food and Drug Control,Shenyang 110036)
出处
《中南药学》
CAS
2020年第7期1178-1180,共3页
Central South Pharmacy
基金
辽宁省自然基金资助计划(No.2019-MS-185)。
