摘要
目的用反相高效液相色谱法(RP-HPLC)测定盐酸利多卡因注射液含量,并将中国药典(2000版)与美国药典(27版)两种方法进行比较. 方法用两国药典方法(反相高效液相色谱法)测定盐酸利多卡因注射液含量.中国药典(2000版)色谱条件:C18柱,以醋酸钠溶液-甲醇(40:60)为流动相,检测波长254 nm.美国药典(27版)色谱条件:C18柱,以醋酸钠溶液-乙腈(4:1)为流动相,检测波长254nm.结果中国药典(2000版)方法盐酸利多卡因在0.1～3.0 g·L-1浓度范围内,浓度与峰面积线性关系良好,相关系数r=0.999 9.美国药典(27版)方法盐酸利多卡因在0.1～3.0 g·L-1浓度范围内,浓度与峰面积线性关系良好,相关系数r=0.999 8.结论二者盐酸利多卡因浓度与峰面积均具有良好的线性关系,峰面积相差不大,无明显差别.
Aim The content of lidocaine was determined by RP-HPLC of different mobile phase with comparison of Chp（ 2000 version） and USP（27 version）. Methods The content of lidocaine was determined by using the RP-HPLC method. The chromatographic conditions at the Chp included the C18 s column and the mobile phase was composed of sodium acetate-methanol （40： 60）. The detection wavelength was 254 nm. The chromatographic conditions at the USP included the C18 column and the mobile phase was composed of sodium acetate - acetonitrile （4：1 ）. The detection wavelength was 254 nm. Results The linearity was obtained over 0.1 - 3.0 g·L^-1 （ r = 0.999 9 ） for lidocaine at the Chp （2000 version ） and the linear relation was good. At the USP（27 version） the linearity was obtained over 0.1 -3.0 g·L^-1 （ r = 0. 9998） and the linear relation was good. Conclusion The two linear relations were very good with the density and the peak area. By compareson with the USP,the peak area of the ChP is similar. There is no distinct differences between the two methods.
出处
《安徽医药》
CAS
2005年第9期666-667,共2页
Anhui Medical and Pharmaceutical Journal
