Ghanem Mashhour M, Abu-Lafi Saleh A
Pharmacare Pharmaceutical Company, P.O. Box 677, Ramallah, Palestine.
Sci Pharm. 2013 Apr-Jun;81(2):459-74. doi: 10.3797/scipharm.1212-30. Epub 2013 Feb 18.
A simple, specific, accurate, and stability-indicating RP-HPLC method was developed and validated for the simultaneous determination of Trimethoprim (TMP) and Sulfadimethoxine sodium (SDMS) in Vetricine(®) oral solution product. The desired separation was achieved on an ODS column (250×4.6 mm i.d., 5 μm) at room temperature. The optimized mobile phase consisted of an isocratic solvent mixture of water:acetonitrile:triethylamine (700:299:1, v/v/v), adjusted to a pH of 5.7 ± 0.05 with 0.2N acetic acid. The mobile phase was fixed at 0.8 ml/min and the analytes were monitored at 254 nm using a photodiode array detector. The effects of the chromatographic conditions on the peaks USP tailing factor, column efficiency, and resolution were systematically optimized. Forced degradation experiments were carried out by exposing TMP, SDMS standards, and the oral solution formulation to thermal, photolytic, oxidative, and acid-base hydrolytic stress conditions. The degradation products were well-resolved from the main peaks and the excipients, thus proving the reliable stability-indicating method. The method was validated as per ICH and USP guidelines (USP34/NF29) and found to be adequate for the routine quantitative estimation of TMP and SDMS in commercially available Vetricine® oral liquid dosage form.
建立并验证了一种简单、特异、准确且具有稳定性指示功能的反相高效液相色谱（RP-HPLC）法，用于同时测定威泰新（Vetricine®）口服溶液产品中的甲氧苄啶（TMP）和磺胺二甲氧嘧啶钠（SDMS）。在室温下，于ODS柱（250×4.6 mm内径，5μm）上实现了所需的分离。优化后的流动相由水：乙腈：三乙胺（700:299:1，v/v/v）的等度溶剂混合物组成，用0.2N乙酸调节至pH 5.7±0.05。流动相流速固定为0.8 ml/min，使用光电二极管阵列检测器在254 nm处监测分析物。系统地优化了色谱条件对峰的USP拖尾因子、柱效和分离度的影响。通过将TMP、SDMS标准品以及口服溶液制剂置于热、光解、氧化和酸碱水解应激条件下进行强制降解实验。降解产物与主峰和辅料得到了很好的分离，从而证明了该方法具有可靠的稳定性指示功能。该方法按照ICH和USP指南（USP34/NF29）进行了验证，结果表明适用于市售威泰新®口服液剂型中TMP和SDMS的常规定量测定。
