Joseph-Charles J, Geneste C, Laborde-Kummer E, Gheyouche R, Boudis H, Dubost J-P
Université Victor Segalen Bordeaux 2, UFR des Sciences Pharmaceutiques, Laboratoire de Chimie Analytique, 33076 Bordeaux Cedex, France.
J Pharm Biomed Anal. 2007 Aug 15;44(4):1008-13. doi: 10.1016/j.jpba.2007.04.002. Epub 2007 Apr 7.
Oseltamivir phosphate (OP) is an antiviral drug that is used in the treatment and prophylaxis of both influenza A and influenza B. It is effective against all known influenza viruses than can infect humans, including pandemic influenza viruses and may be the most appropriate antiviral option against avian influenza caused by H5N1 virus. Tamiflu, the registered trademark used under exclusive license by Roche laboratories with OP as active pharmaceutical ingredient, is considered the best treatment for the bird flu disease. A simple, selective, linear, accurate and precise HPLC method was developed and validated for rapid assay of OP aimed to the quality control of Tamiflu capsules and generic versions. Isocratic elution at a flow rate of 1.2 mL/min was employed on a Zorbax CN column (150 mm x 4.6mm; 5 microm) at ambient temperature. The mobile phase consisted of methanol and 0.04 M formic acid pH 3.0 (50:50, v/v). The UV detection wavelength was 226 nm and 20 microL of sample was injected. Sotalol hydrochloride was used as the internal standard (IS). The retention times for OP and IS were 3.40 and 2.25 min, respectively. The method was successfully applied to commercial pharmaceuticals, Tamiflu and generic versions. The proposed method could be applicable for routine analysis of OP and monitoring of the quality of marketed drugs as possibly counterfeit Tamiflu.
磷酸奥司他韦（OP）是一种抗病毒药物，用于治疗和预防甲型流感和乙型流感。它对所有已知可感染人类的流感病毒均有效，包括大流行性流感病毒，可能是对抗由H5N1病毒引起的禽流感的最合适抗病毒选择。泰米弗氯（Tamiflu）是罗氏实验室以OP作为活性药物成分独家许可使用的注册商标，被认为是禽流感疾病的最佳治疗药物。开发并验证了一种简单、选择性、线性、准确且精密的高效液相色谱法，用于快速测定OP，旨在对泰米弗氯胶囊及其仿制药进行质量控制。在室温下，使用Zorbax CN柱（150 mm×4.6mm；5μm），以1.2 mL/min的流速进行等度洗脱。流动相由甲醇和pH 3.0的0.04 M甲酸（50:50，v/v）组成。紫外检测波长为226 nm，进样量为20μL。盐酸索他洛尔用作内标（IS）。OP和IS的保留时间分别为3.40和2.25分钟。该方法已成功应用于商业药品泰米弗氯及其仿制药。所提出的方法可适用于OP的常规分析以及监测市售药品（如可能假冒的泰米弗氯）的质量。
