Hood Darryl J, Cheung H Y
Pharmaceutical and Chemical Technology Center Ltd., City University of Hong Kong, 83 Tat Chee Avenue, Hong Kong.
J Pharm Biomed Anal. 2003 Jan 1;30(5):1595-601. doi: 10.1016/s0731-7085(02)00539-3.
The present paper describes a simple, accurate and precise reversed phase HPLC method for rapid and simultaneous quantification of codeine phosphate, ephedrine HCl and chlorpheniramine maleate in a cough-cold syrup formulation. Separations were carried out on a Zorbax XDB C8 column (150 x 4.6 mm ID), 5 microm particle size. A gradient elution system was developed using varying percentages of two mobile phases: methanol-glacial acetic acid-triethylamine (980:15:6 v/v) and water-glacial acetic acid-triethylamine (980:15:6 v/v). The elution of the analytes was achieved in less than 7 min with a flow rate of 1.5 ml/min. Detection was by UV absorbance at a wavelength of 254 nm. Quantification of the components in actual syrup formulations was calculated against the responses of freshly prepared external standard solutions. The method was validated and met all analysis requirements of quality assurance and quality control recommended by FDA of the USA.
本文描述了一种简单、准确且精密的反相高效液相色谱法，用于快速同时定量止咳感冒糖浆制剂中的磷酸可待因、盐酸麻黄碱和马来酸氯苯那敏。分离在Zorbax XDB C8柱（内径150×4.6 mm，粒径5微米）上进行。使用两种流动相（甲醇-冰醋酸-三乙胺（980:15:6 v/v）和水-冰醋酸-三乙胺（980:15:6 v/v））的不同比例开发了梯度洗脱系统。以1.5 ml/min的流速在不到7分钟内实现了分析物的洗脱。通过在254 nm波长处的紫外吸光度进行检测。根据新鲜制备的外标溶液的响应计算实际糖浆制剂中各成分的含量。该方法经过验证，符合美国食品药品监督管理局推荐的质量保证和质量控制的所有分析要求。
