Oszi Z, Pethö G
Human Serum Production and Drug Manufacturing Co., Ltd., Tancsics, Hungary.
J Pharm Biomed Anal. 1998 Dec;18(4-5):715-20. doi: 10.1016/s0731-7085(98)00265-9.
A specific reverse-phase HPLC method has been developed for the quantitative determination of polysorbate 20 in various compositions of nasal solutions. This method is based on the acidic hydrolysis of the sorbitan laurate ester followed by the HPLC determination of the free lauric acid. Using this method, polysorbate 20 can effectively be separated and quantitatively determined in matrices containing a wide variety of preservatives, surfactants, and viscosity agents. Sample preparation involves a one-step hydrolysis with sulfuric acid and then a dilution with acetonitrile, prior to injection. The sample is analyzed on a 5-microm octadecylsilane reverse-phase column with a mobile phase of acetonitrile: 0.025 M aqueous di-Sodium hydrogen phosphate, pH = 2.8 (75:25). The column effluent is monitored by UV detection at 210 nm. The validity of the method has been verified with specificity, linearity, recovery, method- and system precisions data. The method is linear for polysorbate 20 from 2.5 to 125 mg ml(-1) range. The limit of detection and limit of quantitation are 0.41 and 0.61 mg ml(-1), respectively.
已开发出一种特定的反相高效液相色谱法，用于定量测定各种鼻腔溶液组合物中的聚山梨酯20。该方法基于失水山梨醇月桂酸酯的酸性水解，然后通过高效液相色谱法测定游离月桂酸。使用该方法，可以在含有多种防腐剂、表面活性剂和增稠剂的基质中有效地分离和定量测定聚山梨酯20。样品制备包括用硫酸进行一步水解，然后在进样前用乙腈稀释。样品在5微米十八烷基硅烷反相柱上进行分析，流动相为乙腈：0.025M磷酸氢二钠水溶液，pH = 2.8（75:25）。通过在210nm处的紫外检测监测柱流出物。该方法的有效性已通过特异性、线性、回收率、方法和系统精密度数据得到验证。该方法对于聚山梨酯20在2.5至125mg ml(-1)范围内呈线性。检测限和定量限分别为0.41和0.61mg ml(-1)。
