摘要
目的建立同时测定抗敏止痒乳膏中有效成分盐酸利多卡因和马来酸氯苯那敏的高效液相色谱(HPLC)法。方法采用ODS2柱进行分离,流动相为25 mmol·L^(-1)磷酸二氢钾溶液-乙腈(80∶20,V/V,用50%磷酸溶液调节p H值至2.8),柱温为24℃,流速为0.9 m L·min-1,检测波长为262 nm。结果乳膏基质对有效成分的测定无干扰,盐酸利多卡因在57.08~456.64μg·m L^(-1),马来酸氯苯那敏在26.32~210.56μg·m L^(-1)的浓度范围内,进样浓度与峰面积呈良好的线性关系,相关系数均为0.999 8;加样回收率分别为97.2%和95.8%;日内精密度以峰面积考察,RSD分别为1.6%和2.3%;日间精密度RSD分别为2.6%和3.4%。结论该方法简单、快捷,可用于该乳膏剂的质量控制。
OBJECTIVE To establish a simple and rapid method to determine lidocaine hydrochloride and chlorphenamine maleate in anti-allergic and itching relieving cream by high performance liquid chromatography. METHODS A Hypersil ODS2 column was used for sepration,the mobile phase containing 25 mmol potassium phosphate monobasic solution and acetonitrile（80∶20,V/V）（ adjusted to pH 2. 8 with 50% phosphoric acid solution）,Column temperature ： 24 ℃,Flow rate： 0. 9 m L·min^-1,Detection wavelength： 262 nm. RESULTS The cream base is not interfered with determination. Lidocaine hydrochloride and chlorphenamine maleate have a good linear calibration curve in the range of 57.08-456.64 μg·m L^-1（ r= 0.999 8） and 26.32-210.56 μg·m L^-1（ r= 0.999 8）.The spiked recovery was 97.2% and 95.8%.The intra-day precision RSDs of peak area are 1.6% and 2. 3%,and inter-day 2. 6% and3.4% respectively. CONCLUSION The method is simple and convenient for the quality control of anti-allergic and itching relieving cream.
出处
《今日药学》
CAS
2018年第2期92-94,共3页
Pharmacy Today
关键词
抗敏止痒乳膏
盐酸利多卡因
马来酸氯苯那敏
高效液相色谱
anti-allergic and itching relieving cream
lidocaine hydrochloride
chlorphenamine maleate
HPLC
