RP-HPLC法检测甲磺酸帕珠沙星注射剂中右旋体含量

Determination of Dextrogyre in Pazufloxacin Monomethanesulfon ate Injection

目的 :建立RP HPLC法检测甲磺酸帕珠沙星注射剂中右旋体含量。方法 :采用岛津C1 8柱 (4 6mm× 2 5 0mm ,5 μm) ,流动相为甲醇 手性溶液 (30∶70 ) ,流速为 1 0mL min ,紫外检测波长为 32 0nm。 结果 :甲磺酸帕珠沙星右旋体的保留时间为 6 8min ,其浓度在 12 5 2～ 37 5 4 μg mL范围内 ,呈良好的线性关系 (r =0 9995 ,n =5 ) ,平均回收率为 99 16 % ,RSD为 0 33% (n =5 )。结论 :本法简便快速 ,精密度良好 ,可作为甲磺酸帕珠沙星制剂的质量控制方法。

Objective:To estatlish a R P -HPLC method for the determination of the dextrogyre in pazuflox- acin monome than esulfonate Injection. Methods: Shimadzu C 18 Column (4.6 m m×250 mm,5 μm) and MeOH-chiral solution (30∶70) as mobile phase were used a t a flow rate of 1.0 mL/min and at a detection wavelengh of 320 nm. Res ults: The retention time of the dextrogyre in pazufloxacin monomethanes ulfonate was 6.8 min. A good linear relationship was shown in the concentration range of 12.52～37.54 μg/mL(r=0.9995,n=5). The average recovery was 99.16%, with RSD of 0.33% (n=5). Conclusion: The meth od is simple, rapid, accurate and repeatable. It can be used for determination o f dextrogyre in pazufloxacin monomethanesulfonate preparation to control its quality. [