力达霉素标准品量值传递方法的研究

Study of A Potency Value Transmission Method for Lidamycin Reference Standard

目的:建立力达霉素标准品量值传递的方法。方法:选用稳定物质头孢唑林为表征性参比物质;通过HPLC测定表征性参比物质与力达霉素发色团的标准曲线,以其斜率的比值表征二者的摩尔紫外吸收系数比值,并作为校正因子;通过表征性参比物质的量值结合校正因子来传递力达霉素的量值。结果:表征性参比物质与力达霉素的校正因子为36.58,RSD为2.5%(n=6)。结论:通过校正因子可将力达霉素标准品的量值准确的传递下去。

Objective:To establish a potency value transmission method for national reference standard of lidamycin. Methods: Cefazolin was selected as an deputy reference substance. Calibration curves of both the deputy reference substance and lidamycin chromophore were determined by HPLC and the slope ratio of these two curves was defined as a calibration factor, which could represent the ratio of the two mole ultraviolet absorption coefficients. Thus, the potency value of lidamycin reference standard could be transmitted by the value of the deputy reference substance combining the calibration factor. Results:The calibration factor is 36. 58 with RSD 2. 5% (n =6). Con elusion: The potency value of Lidamycin reference standard could be transmitted accurately to keep constant contin ously.