摘要
目的建立同时测定多效防护霜中盐酸苯海拉明、甲氧基肉桂酸辛酯和水杨酸辛酯的含量的方法。方法采用高效液相色谱法。色谱柱为Agilent Extend-C18(4.6 mm×150 mm,5μm),流动相为甲醇-乙酸铵缓冲溶液(20 mmol/L,pH=7.5),梯度洗脱,甲醇比例随时间变化为:0~10 min、甲醇→60%;10~12 min、甲醇60%→92%;12~20 min、甲醇→92%,采集时间20 min,平衡时间10 min,流速1 ml/min,紫外检测波长218 nm,柱温25℃,进样量15μl。结果3种成分在30 min内基线分离,方法学验证表明,线性关系良好(r>0.9995),日内日间精密度均小于3.0%,回收率在90%~108%之间,稳定性和重复性RSD均<3.0%,符合方法学要求。按照新建立的方法测定了3个批次样品中3种成分的含量,结果符合要求。结论本方法简便可靠,可为多效防护霜的质量控制提供依据,也为其质量标准研究奠定了基础。
Objective To establish a HPLC method for the simultaneous determination of diphenhydramine hydrochloride,octyl methoxycinnamate and octyl salicylate in multi-effect protective cream.Methods The HPLC condition was as follows.The column was Agilent Extend-C18(4.6 mm×150 mm,5μm).The mobile phase was methanol and ammonium acetate buffer solution(20 mmol/L,pH=7.5).Gradient elution.The methanol ratio varies with time as follows:0-10 min,methanol→60%;10-12 min,methanol 60%→92%;12-20 min,methanol→92%.Acquisition time was 20 minutes.Liquid phase equilibrium time was 10 min.Flow rate was 1 ml/min.UV detection wavelength was 218 nm.Column temperature was 25℃.Injection volume was 15μl.Results The three components were separated at baseline within 30 min.The methodological verification showed that the standard curves had good linearity(r>0.9995).The inter-day precision were less than 3.0%.The recovery was between 90%and 108%.The RSD%of stability and repeatability were also less than 3.0%.The results showed that the method could meet the requirements of method validation.The contents of the three components in three batches were determined according to the newly established method.Conclusion The method is simple and reliable,can provide a basis for the quality control of multi-effect protective cream,and laid a foundation for its quality standard research.
作者
韩凌
王新霞
吕磊
张静如
阚月一
鲁莹
傅翔
HAN Ling;WANG Xinxia;LV Lei;ZHANG Jingru;KAN Yueyi;LU Ying;FU Xiang(Department of Pharmacy,Shanghai Kongjiang Hospital,Shanghai 200093,China;Department of Pharmacy,Shanghai Eastern Hepatobiliary Surgery Hospital,Shanghai 200438,China;School of Pharmacy,Naval Medical University,Shanghai 200433,China)
出处
《药学实践杂志》
CAS
2019年第6期508-511,共4页
Journal of Pharmaceutical Practice
基金
国家科技重大专项资助项目(2018ZX09J18110-001-001)
关键词
多效防护霜
高效液相色谱
盐酸苯海拉明
甲氧基肉桂酸辛酯
水杨酸辛酯
含量测定
multi-effect protective cream
HPLC
diphenhydramine hydrochloride
octyl methoxycinnamate
octyl sa-licylate
content determination
