Tzanavaras Paraskevas D, Themelis Demetrius G
Quality Control Department, Cosmopharm Ltd., P.O. Box 42, Korinthos 20100, Greece.
J Pharm Biomed Anal. 2007 Mar 12;43(4):1526-30. doi: 10.1016/j.jpba.2006.11.002. Epub 2006 Dec 4.
Acyclovir and its major impurity guanine are determined rapidly by the incorporation of a monolithic column (100 mm x 4.6 mm i.d., Merck) to an automated HPLC system. A simple flow gradient protocol was adopted in order to accelerate the separation-detection cycle. Using 0.2% CH(3)COOH (pH 3.1) as the mobile phase and detection at 254 nm, guanine was effectively separated from the system peak (t(R)=1.25 min), while the retention time of acyclovir was 2.35 min. Linearity of the assay was validated in the range 0.1-1.0% guanine and 80-120% acyclovir (n=5). The accuracy and within- and day-to-day precision of the method were also validated, while the limits of detection and quantitation of both analytes were determined. The proposed method was successfully applied to the quality control of acyclovir raw material and the quality and stability control of acyclovir-containing pharmaceutical creams (Hagevir 5%, w/w, Cosmopharm Ltd., Korinthos, Greece).
通过将整体柱（100 mm×4.6 mm内径，默克公司）与自动高效液相色谱系统联用，可快速测定阿昔洛韦及其主要杂质鸟嘌呤。采用简单的流动梯度程序以加速分离检测循环。以0.2%的CH(3)COOH（pH 3.1）作为流动相，在254 nm处进行检测，鸟嘌呤可有效与系统峰分离（保留时间t(R)=1.25分钟），而阿昔洛韦的保留时间为2.35分钟。该测定方法在0.1 - 1.0%的鸟嘌呤和80 - 120%的阿昔洛韦范围内进行了线性验证（n = 5）。还验证了该方法的准确性以及日内和日间精密度，同时确定了两种分析物的检测限和定量限。所提出的方法成功应用于阿昔洛韦原料药的质量控制以及含阿昔洛韦药用乳膏（Hagevir 5%，w/w，希腊科林斯Cosmopharm有限公司）的质量和稳定性控制。
