高效毛细管电泳法测定盐酸伐昔洛韦含量及有关物质

Capillary zone electrophoresis determination of valacyclovir hydrochloride and its related substances

目的:建立测定盐酸伐昔洛韦含量及有关物质的高效毛细管区带电泳方法。方法:采用非涂层渍石英毛细管;运行缓冲溶液为30mmol·L^(-1)硼砂缓冲液(pH9.6);运行电压:25kV;柱温为25℃;检测波长:251nm;用水制备样品溶液,含量测定时样品溶液浓度为250μg·mL^(-1),有关物质测定时样品溶液浓度为5mg·mL^(-1);压力进样5s(进样口压力2.5kPa)。结果:盐酸伐昔洛韦中的主要杂质有1个,水解、酸解、碱解、氧化中产生的诸杂质彼此之间与盐酸伐昔洛韦之间可得到有效的分离;在50～500μg·mL^(-1)浓度范围内线性关系良好,r=0.9996(n=6),平均回收率为99.64%,RSD=1.3%(n=6)。结论:毛细管电泳法分析盐酸伐昔洛韦含量与有关物质,该法简便、灵敏、准确,专属性强,可用于企业生产过程中的质量控制。

Objective： To establish the capillary zone electrophoresis method （CZE） for determination of content and related substances of valacyclovir hydrochloride. Method： The uncoated fused - silica capillary. The running buffer system consisted of borax buffer （pH 9. 6）. The separation voltage was 25 kV and the capillary temperature was 25 ℃. The detection wavelength was 251 nm. The sample was dissolved in water with a concentration of 5 mg · mL^ -1 and 250μg·mL^-1 respectively for content assay and impurity determination, and was injected to the column by pressure（2. 5 kPa） for 5s. Results： One impurity in valacyclovir hydrochloride could be detected. Valacyclovir hydrochloride and the degradations by acid hydrolysis, alkaline hydrolysis and oxidation could be separated well. The calibration curve of valacyclovir hydrochloride was linear in the range of 50 - 500 μg·mL^-1 and the corretation coefficient was 0. 9996 （ n = 6）. The average recovery was 99.64%, （ RSD = 1.3 % , n = 6 ） Conclusion： The meth- od is simple, sensitive, accurate and can be complement to HPLC method for determination of valacyclovir hydrochloride. It can be used for quality control of valacyclovir hydrochloride in production.