Ali Mohammed Shahid, Ghori Mohsin, Khatri Aamer Roshanali
Jamoom Pharmaceuticals, Industrial Area, Phase-5, P.O. Box No. 6267, Jeddah 21442, Saudi Arabia.
J Pharm Biomed Anal. 2006 May 3;41(2):358-65. doi: 10.1016/j.jpba.2005.12.026. Epub 2006 Feb 7.
A simple, specific and precise high performance liquid chromatographic method has been developed and validated for the simultaneous determination of methylparaben (MP), propylparaben (PP), and domperidone (DP) in oral suspension. Isocratic mobile phase consists of 0.5% w/v aqueous ammonium acetate buffer:methanol, 40:60 (v/v). Column containing octylsilyl chemically bonded to porous silica particles (Optimapak, OP C8, 150 mmx4.6 mm, 5 microm, stainless steel analytical column from RS tech) is used as stationary phase. The detection is carried out using variable wavelength UV-vis detector set at 280 nm. The solutions are chromatographed at constant flow rate of 1.0 mL/min. The method separates MP, PP, DP and droperidol (DR) impurity in less than 12 min with good resolution, peak shapes and minimal tailing. Retention times (RT) for MP, PP, DP and DR are about 3.4, 7.0, 9.0 and 10.9 min, respectively. Linearity range and percent recoveries for MP, PP and DP are 90-270, 10-30, 50-1500 microg/mL and 100.30%, 100.78% and 100.48%, respectively. Method was validated according to ICH guidelines and proved to be suitable for stability testing, homogeneity testing and quality control of these compounds in pharmaceutical preparations.
已开发并验证了一种简单、特异且精确的高效液相色谱法，用于同时测定口服混悬液中的对羟基苯甲酸甲酯（MP）、对羟基苯甲酸丙酯（PP）和多潘立酮（DP）。等度流动相由0.5% w/v乙酸铵水溶液缓冲液：甲醇，40:60（v/v）组成。含有键合到多孔硅胶颗粒上的辛基硅烷基的色谱柱（Optimapak，OP C8，150 mm×4.6 mm，5微米，RS tech的不锈钢分析柱）用作固定相。使用设置在280 nm的可变波长紫外可见检测器进行检测。溶液以1.0 mL/min的恒定流速进行色谱分离。该方法在不到12分钟内分离出MP、PP、DP和氟哌利多（DR）杂质，分离度良好，峰形良好且拖尾最小。MP、PP、DP和DR的保留时间（RT）分别约为3.4、7.0、9.0和10.9分钟。MP、PP和DP的线性范围和回收率分别为90 - 270、10 - 30、50 - 1500 microg/mL和100.30%、100.78%和100.48%。该方法根据ICH指南进行了验证，证明适用于这些化合物在药物制剂中的稳定性测试、均匀性测试和质量控制。
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