摘要
目的改进咳特灵片的质量标准。方法采用高效液相色谱(HPLC)法对马来酸氯苯那敏进行定性鉴别,改进小叶榕的薄层色谱鉴别方法;采用HPLC法对马来酸氯苯那敏进行含量测定,色谱柱为Phenomenex C18柱(250 mm×4.6 mm,5μm),以0.05 mol/L磷酸二氢钾溶液(含1%三乙胺和0.005 mol/L庚烷磺酸钠,用磷酸调节pH至3.0)-甲醇(40∶60)为流动相,检测波长264 nm,进样量10μL。结果薄层色谱特征明显,专属性强;马来酸氯苯那敏质量浓度在10.89～108.90μg/mL范围内与峰面积线性关系良好(r=0.999 9),平均回收率为99.79%,RSD为1.06%(n=6)。结论该方法准确、专属性强、重现性好,可用于该药的质量控制。
Objective To improve the quality standard of Keteling Tablets.Methods Chlorpheniramine maleate was qualitatively identi-fied by HPLC;the TLC method for identifying ficus microcarpa was improved;chlorphenamine maleate was quantitatively determined by HPLC.The Phenomenex C18 column（250 mm×4.6 mm,5 μm） was used with the mobile phase of methanol-0.05 mol/L potassium dihydrogen phosphate（containing 1% triethylamine and 0.005 mol/L sodium heptanesulfonate,adjusting pH to 3.0 with phosphoric acid）（60 ∶40）.The detection wavelength was 264 nm.The injected quantity was 10 μL.Results The chromatographic characteristic of TLC was remarkable with strong specificity.Chlorpheniramine maleate showed good linear relation in the range of 10.89-108.90 μg/mL（r=0.999 9） and its average recovery rate was 99.79%,RSD=1.06%（n=6）.Conclusion These methods are accurate with strong specificity and good reproducibility and can be used for the quality control of Keteling Tablets
出处
《中国药业》
CAS
2013年第4期42-43,共2页
China Pharmaceuticals
