摘要
目的采用HPLC法测定复方醋氯芬酸缓释微丸中醋氯芬酸和对乙酰氨基酚的含量,并对其质量稳定性进行考察。方法色谱柱为C18柱(200 mm×4.6 mm,5μm),流动相为乙腈-50 mmol·L-1醋酸铵水溶液梯度洗脱,检测波长为275 nm,流速为1.0 mL·min-1,柱温为30℃。结果醋氯芬酸的质量浓度在2.0~24 mg·L-1内与峰面积呈良好的线性关系(r=0.999 9),平均回收率为97.1%,RSD为0.30%;对乙酰氨基酚的质量浓度在10~120 mg·L-1内与峰面积呈良好的线性关系(r=0.999 9),平均回收率为98.2%,RSD为0.39%,初步稳定性试验表明,微丸的性状、含量均无明显变化,杂质含量少。结论建立的含量测定方法简单、快速、准确,自制缓释微丸制剂质量稳定。
Objective To establish an HPLC method for the determination of aceclofenac and acetaminophen in compound aceclofenac substained-release pellets and to investigate the stability.Methods C18 column(200 mm×4.6 mm,5μm)was used and the mobile phase was consisted of acetonitrile-50 mmol·L-1 ammonium acetate aqueous solution with gradient elution.The detective wavelength was 275 nm.The flow rate was 1.0 mL·min-1 and the column temperature was 30℃.Results The linearly related of aceclofenac was 2.0-24 mg·L-1(r=0.999 9),the average recovery was 97.1%with a RSD of 0.30%;The of concentration acetaminophen was linear with the peak area in the range of 10.0-120 mg·L-1(r=0.999 9),the average recovery was 98.2%with a RSD of 0.39%.The preliminary stability test showed that the properties and the contents of the pellets were no significant difference and less impurity.Conclusion The established content determination method is simple,rapid and accurate,and the quality of sustained-release pellets is stable.
作者
程侯连
杜学勤
王增仙
甄会贤
田燕元
CHENG Houlian;DU Xueqin;WANG Zengxian;ZHEN Huixian;TIAN Yanyuan(Department of Pharmacy,Shanxi Pharmaceutical College,Taiyuan 030031,China;School of Traditional Chinese Materia Medica,Jiangxi University of Traditional Chinese Medicine,Nanchang 330004,China)
出处
《沈阳药科大学学报》
CAS
CSCD
北大核心
2019年第9期818-822,共5页
Journal of Shenyang Pharmaceutical University
基金
山西省高等学校科技创新项目(20151119)
关键词
复方醋氯芬酸缓释微丸
含量
稳定性
compound aceclofenac substained-release pellet
content
quality stability
