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目的:采用高效液相色谱法测定喷昔洛韦注射剂的含量,探讨高效液相色谱法考察注射剂的质量。方法:以HypersilC18柱为固定相,以磷酸盐缓冲液-甲醇(65:35)为流动相,于254nm波长处检测,流速为1.0mL.min-1。结果:喷昔洛韦质量浓度在10～50mg.L-l范围内与峰面积呈良好线性关系。喷昔洛韦保留时间为4.2min,方法的精密度和稳定性的RSD均小于3%,回收率大于98%。用此方法测定的喷昔洛韦注射剂的相对百分含量为99.82%。结论:本法操作简便、快速,结果准确可靠,重复性好,可用于测定喷昔洛韦注射剂的含量。
Objective: To determine the content of penciclovir injection by high performance liquid chromatography (HPLC) and to investigate the quality of injection by high performance liquid chromatography. Methods: Hypersil C18 column was used as the stationary phase and phosphate buffer-methanol (65:35) as the mobile phase at a wavelength of 254 nm. The flow rate was 1.0 mL · min-1. Results: The concentration of penciclovir in the range of 10 ~ 50mg.L-l showed a good linear relationship with the peak area. Penciclovir retention time of 4.2min, the precision and stability of the RSD were less than 3%, the recovery rate was greater than 98%. The relative percentage of penciclovir injections measured by this method was 99.82%. Conclusion: The method is simple, rapid, accurate and reliable, reproducible, and can be used to determine the content of penciclovir injection.