A validated stability indicating reverses phase liquid chromatographic method for the determination of valacyclovir

S. S. Shaikh, V. K. Padri
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引用次数: 0

Abstract

A simple reverse phase liquid chromatographic method with ultraviolet detector was developed for the accurate determination of Valacyclovir using GracesmartRP18, C18 Column (250 mm × 4.6 mm, 5μm particle size). The mobile phase used for the determination was Methanol: Citric Acid buffer in a ratio of 60: 40 v/v at a flow rate of 1.0 mL per min. Valacyclovir was eluted at 2.2 ± 0.1 min and detected at 254 nm. The method is linear over the concentration range of 10-50 µg/mL with correlation co-efficient r = 0.999. The plate count and tailing factor was found 3847 and 1.24 respectively. The developed method was proved to be robust after extensively validated with different parameters such as Linearity, Precision, Accuracy, Robustness, Ruggedness, Limit of Detection (LOD), Limit of Quantification (LOQ) and specificity. The validated method is definite, meticulous and reproducible and can be used for routine analysis of Valacyclovir in bulk form.
反相液相色谱法测定伐昔洛韦的稳定性
采用GracesmartRP18, C18色谱柱(250 mm × 4.6 mm, 5μm粒径),建立了紫外检测器反相液相色谱法准确测定伐昔洛韦的方法。流动相为甲醇:柠檬酸缓冲液,比例为60:40 v/v,流速为1.0 mL / min。Valacyclovir洗脱时间为2.2±0.1 min,检测波长为254 nm。该方法在10 ~ 50µg/mL浓度范围内线性良好,相关系数r = 0.999。板数和尾因子分别为3847和1.24。在线性度、精密度、准确度、鲁棒性、坚固性、检出限(LOD)、定量限(LOQ)和特异性等参数的基础上,验证了该方法的鲁棒性。该方法确定、细致、重现性好,可用于原料药伐昔洛韦的常规分析。
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