相对校正因子法测定缬沙坦中缬沙坦苄酯的含量-中国药品标准杂志.DOC

相对校正因子法测定缬沙坦中缬沙坦苄酯的含量 邱少华（临沂市食品药品检验检测中心，临沂 276000） 摘要目的：建立缬沙坦原料药及制剂中缬沙坦苄酯的含量测定方法。方法：采用反相高效液相色谱加校正因子的主成分自身对照法；色谱柱为C18柱，流动相为水-乙腈（1∶1）(用冰醋酸调节pH值至2.5），检测波长245 nm，流量为1.0 mL·min-1； 测定缬沙坦和缬沙坦苄酯的标准曲线方程，以斜率计算缬沙坦苄酯相对缬沙坦的校正因子，用相对保留时间对缬沙坦苄酯进行定位。结果：缬沙坦苄酯的相对保留时间为5.4，相对校正因子为0.88；对13批样品中缬沙坦苄酯的含量进行测定，测得结果与对照品法测定结果一致。结论：该方法专属性强，灵敏度高，可准确有效地测定缬沙坦中缬沙坦苄酯的含量。 关键词：缬沙坦；缬沙坦苄酯；相对校正因子；含量测定 Determination of Valsartan Benzyl Ester in Valsartan by Relative Correction Factor Method Qiu Shaohua （Linyi Institute for Food and Drug Control , Linyi 276000） Abstract Objective: To establish a method for the determination of Valsartan Benzyl Ester in Valsartan raw materials and tablets. Methods: HPLC and Main component self-comparison with correction factor method were adopted. The determination was performed on a C18 column with water and acetonitrile (1:1)( adjusted pH to 2.5 with acetic acid) as the mobile phase, the flow rate was 1.0 mL穖in-1 tand the detection wavelength was 245nm. The linear equations of Valsartan and Valsartan Benzyl Ester were determined, slopes were used to calculate the relative correction factor of Valsartan Benzyl Ester to Valsartan and relative retention time was used to determine the position. Results:The relative retention time of Valsartan Benzyl Ester was 5.4 and the relative correction factor was 0.88. 13 batches of samples were determined by relative correction factor method (RCFM) and standard curve method (SCM), there were no differences in the results between the two methods. Conclusion: The method is specific and sensitive, it can be used for the quantitative analysis of Valsartan Benzyl Ester in Valsartan tablets and raw materials.Key words: Valsartan; Valsartan Benzyl Ester; relative correction factor; content determination 缬沙坦（valsartan）化学名为N-戊酰基-N-[[2＇-（1H-四氮唑-5-基）[1,1＇-联苯]-4-基]甲基]-L-缬氨酸，是一种高选择性Ⅰ型血管紧张素Ⅱ受体拮抗剂，具有良好的抗高血压作用，适用于各种类型轻、中度高血压，尤其对血管紧张素转换酶抑制剂不能耐受的患者，且无致咳的不良反应。缬沙坦原料药及制剂标准收载于《中国药典》(ChP)2015年版[1]中，在《美国药典》（USP）[2]、《欧洲药典》(EP) [3]、《英国药典》（BP）[4]和《日本药局方》（JP）