QN-CSFH-101 尼泊金甲酯、丙酯测试方法(rev 8 ) 2.docVIP

目的与范围 Scope and Purpose 用HPLC测定中尼泊金酯的含量This method is applicable to the determination of Phenoxyethanol, Methyl Paraben and Propyl Paraben by HPLC in Dabao products. 特殊安全防范措施 根据化学试剂的材料安全数据表来进行相应的安全操作与防护。 Use Material Safety Data Sheets (MSDS) regarding the safe handling of chemicals specified. 方法原理 通过采用梯度洗提，用HPLC和C-18反相色谱柱将尼泊金酯从品中和其它组份相互分离开。用外标法进行定量。Phenoxyethanol and Parabens are separated from each other as well as from other components in the sample by gradient elution HPLC using a C-18 reverse phase column. The components are detected using an UV detector 254 nm and quantitated by a method of external standardization. 基本方程式 无 干扰因素 任何和尼泊金酯具有相同保留时间的化合物都可能产生干扰。Under the conditions prescribed, the method is selective/specific and no interferences are evident 精确度与准确度 无None 仪器 装备紫外检测器的液相色谱色谱柱：Dabao Eye Bag Cream (F# WJ238-40394)）0.45μm PVDF或者类似型号针头式过滤器 Filters, 0.45 μm PTFE filters or equivalent HPLC进样瓶Auto sampler vials 50毫升，00毫升容量瓶volumetric flask 2毫升，5毫升移液管 试剂R 去离子水Purified water (Milli Q) or equivalent 乙腈（HPLC级）HPLC Grade Acetonitrile or equivalent 甲醇（HPLC级）Methanol HPLC Grade or equivalent （AR）Acetic acid AR Grade or equivalent 尼泊金酯 ，有已知含量和失效期Methyl paraben, Reference standard with known purity. 尼泊金酯 ，有已知含量和失效期Propyl paraben, Reference standard with known purity.2-phenoxyethanol, Reference standard with known purity. 标准溶液配制Standard Preparation 准确称取标至00ml的容量瓶中，准确至0.1毫克。Into a single 100 ml volumetric flask, weigh each of the following 尼泊金甲酯Methyl Paraben 0.05g 尼泊金丙酯Propyl Paraben 0.03g 苯氧乙醇 Phenoxyethanol 0.13g 用甲醇溶解并稀释至刻度并混合均匀。(储备液)Dilute to volume with Methanol (8.3) and mix thoroughly (Stock standard) 移取.0ml储备液于0毫升容量瓶中，用甲醇稀释至刻度并混合均匀（标）。Pipet 5.0 ml of the diluted standard in to a 50 ml volumetric flask, dilute to volume with Methanol and mix thoroughly (Working standard) 通过0.45μm过滤工作标准样品于HPLC样品瓶中。Filter approximately 2-3 ml through a 0.45μm PVDF filter (7.3) in to an autosampler vial. Discard the first 1-2 ml through the f