HPLC测定小儿双扑伪麻片3组分及含量均匀度

 目的：研究和寻找能准确测定小儿双扑伪麻片中3组分含量的简便方法。方法：采用高效液相色谱法，以2种不同的样品浓度，同一流动相，同一内标，2次进样测定3组分含量，可在20min内完成。结果：本方法线性范围：对乙酰氨基酚为1．5μg·ml^－1～7．5μg·ml^－1，r＝0．9993；盐酸伪麻黄碱为0．12mg·ml^－1～0．36mg·ml^－1，r＝0．9995；马来酸氯苯那敏为8μg·ml^－1～24μg·ml^－1，r＝0．9971。平均回收率（x％）及变异系数（RSD％）分别为：对乙酰氨基酚（99．8±1．7）；盐酸伪麻黄碱（99．8±1．2）、马来酸氯苯那敏（98．7±1．5）。结论：本方法可用于小儿双扑伪麻片的含量测定；外标法可用于盐酸伪麻黄碱、马来酸氯苯那敏的含量均匀度测定。

HPLC determination of 3 components in compound of paracetamol, pseudoephedrine hydorochloride and chlorphenamine maleate tablets for children and uniformity of content

OBJECTIVE: To find a precise, simple and convenlent method for determination of 3 components in compound of paracetamol, pseudoephedrine hydrochloride and chlorphenamine maleats tablets for chlidren. METHOD: HPLC was used to determine 3 components. The sample solutions were prepared at two concentration levels, and mobile phase, internal standard were same. The 3 components were determined in 20 minutes. RESULTS: A better linearity and good correlation coefficient were obtained from 1.5 μg·ml^-1～7.5 μg·ml^-1 of paracetamol (r＝0.999 3), 0.12 mg·ml^-1～0.36 mg·ml^-1 of pseudoephedrine hydrochloride (r＝0.999 5), 8 μg·ml^-1～24 μg·ml^-1 of chlorphenamine maleate (r＝0.997 1). The mean recoveries and RSD of paracetamol, pseudoephedrine hydrochloride and chlorphenamine maleate were (99.8±1.7), (99.8±1.2) and (98.7±1.5) respectively. CONCLUSION: The results show that the method is suitable for determination of 3 components in the compound. The external standard method is used to determine uniformity of content.