反相高效液相色谱法测定软膏中阿昔洛韦含量的建立与验证

Ajay B. Bedadurge, Kadare Mahesh, Vinod Matole, Parikshit D. Shirure, Sainath Suryawanshi, Ghodake Kajal
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引用次数: 1

摘要

建立了高效液相色谱法测定软膏中阿昔洛韦的方法,并进行了验证。采用Luna C18色谱柱(250 × 4.6mm × 5µ)进行分离。流动相为水:乙腈,比为88:12,流速0.8ml/min,二极管阵列检测器波长254nm。柱温调节为30℃±40℃,进样量20µl。阿昔洛韦的保留时间为4.747min。在80 ~ 120µg/ml浓度范围内,校准曲线呈线性关系(r2=0.9996)。验证按照ICH指南进行。该方法简便、快速、线性、精密度、准确度、一致性好。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Development and Validation of RP-HPLC Method for Determation of Acyclovir in Ointment
The analytical method was developed and validated for determination of acyclovir in ointment by High performance liquid chromatography. The separation was carried out on Luna C18 column (250 × 4.6mm × 5µ). The mobile phase consists of water: acetonitrile in the ratio 88:12 at flow rate 0.8ml/min with diode array detector wavelength at 254nm.The column temperature was adjusted at 30ºC±40ºC with injection volume 20µl.The retention time of acyclovir was 4.747min. The linearity of the calibration curve was linear over the concentration range 80-120µg/ml (r2=0.9996). The validation was carried out as per ICH guidelines. The development method was easy, rapid, linear, precise, accurate and consistent.
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