Determination of Content and Related Substance of Valacyclovir Hydrochloride Dispersible Tablets by Crownpak CR( +)-HPLC / 中国药师

ABSTRACT

Objective:To establish a Crownpak CR( +)-HPLC method for the determination of the content and related substance of valacyclovir hydrochloride dispersible tablets. Methods: A Crownpak CR( +) [4. 0 mm × 150 mm,5 μm,DAICEL CROWNPAK CR( +)] column was used,and the mobile phase was 0. 1% perchloric acid in water. The flow rate was 0. 75 ml·min-1 and the de-tection wavelength was 255 nm. Results: A good linear range of valacyclovir hydrochloride was 11. 25-180. 00 μg · ml-1 ( r =1. 000 0), and the average recovery was 99. 0%(RSD=0. 8%, n=9). A good linear range of alacyclovir was 0. 2-50μg·ml-1(r=1. 000 0), and the average recovery was 99. 3%(RSD=0. 6%, n=9). The content of the tablets from two pharmaceutical companies was 92. 7% and 97. 4%, respectively, that of acyclovir calculated by an external standard method was 0. 5% and 0. 4%, respectively, and that of D-valacyclovir calculated by a self-control method was 0. 9%. Conclusion:The method can effectively separate valacyclovir and D-valacyclovir, which is simple, accurate and reliable, and suitable for the quantity control of valacyclovir hydrochloride.