小儿热咳口服液质量控制研究

Quality Control of Pediatric Cough Oral Liquid

目的:修订小儿热咳口服液的含量测定方法,提高质量控制方法。方法:采用高效液相色谱法测定小儿热咳口服液盐酸麻黄碱和伪麻黄碱的含量。以十八烷基硅烷键合硅胶为填充剂;以乙腈-0.1%磷酸溶液(含0.1%三乙胺)(3∶97)为流动湘;检测波长为206nm。结果:盐酸麻黄碱定量限为21ng,盐酸伪麻黄碱定量限为22ng;盐酸麻黄碱在85.34ng^1280.1ng,盐酸伪麻黄碱在45.16~677.4ng,线性关系良好;6份本品精密度实验,结果盐酸麻黄碱均值0.21mg/m L(RSD=1.6%),盐酸伪麻黄碱均值0.0546mg/m L(RSD=1.9%);加样回收率在98.6-100.2%(RSD=0.6%)。结论:该方法的专属性及耐用性均较好,适用于本品的含量控制。

objective：To modify the method for determining the content of pediatric cough oral liquid by HPLC.Method： determining the content of Ephedrine hydrochloride and Pseudoephedrine hydrochloride in pediatric cough oral liquid by HPLC.Eighteen alkyl silane bonded silica gel as filler.Acetonitrile-0.1％ phosphoric acid solution （containing 0.1％ ethylamine） （3：97） was used as mobile phase.The detection wavelength was 206nm.Result：The quantitation limit of ephedrine hydrochloride was 21ng.The limit of quantitation was 22ng of pseudoephedrine hydrochloride.Ephedrine hydrochloride in 85.34ng-1280.1ng,Pseudoephedrine hydrochloride in 45.16ng-677.4ng, they had good linear correlation.the mean of the precision test of 6 copies was 0.21mg/mL （RSD=1.6％） of ephedrine hydrochloride, 0.0546mg/mL（RSD=1.9％）of pseudoephedrine hydrochloride.the recovery rate was between 98.6-100.2％ （RSD=0.6％）.Conlusion：The method has good specificity and durability, and is suitable for the content control of the product.