一种高效、精确的新型高效液相色谱法同时测定西多福韦和泛昔洛韦的含量

Rafi Syed, Kirankumar Ch, Gidyonu Paleti
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摘要

采用Symmetry C-18 150x4.6mm, 3.5柱,流速为1ml/min,定量分析西多福韦和famciclovir,开发了一种全新、有效、准确的高效液相色谱方法。乙腈和缓冲液以60:40的比例混合用于流动阶段,缓冲液是通过将1ml甲酸溶解在1l HPLC水中产生的。检测波长为250 nm。运行8分钟后,西多福韦和泛昔洛韦的峰分离,前峰洗脱时间2.8分钟,后峰洗脱时间6.4分钟。西多福韦在7.5 g/ml ~ 112.5 g/ml、泛环洛韦在25 g/ml ~ 375 g/ml的浓度范围内呈良好的线性关系。精密度和回收率在98 ~ 102%之间。在任何稳健性情况下,RSD百分比小于2.0%。在压力下,恶化几乎没有影响,解决方案在一整天内都有效。对精密度、准确度、特异性、稳定性、稳健性、线性、检出限和定量限等参数进行评价,发现在按照ICH指南设计和验证方法时均在可接受范围内。
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A brand-new efficient and precise high performance liquid Chromatographic Method for Simultaneous Estimation of Cidofovir and Famciclovir
The quantitative analysis of cidofovir and famciclovir using a Symmetry C-18 150x4.6mm, 3.5 column with a flow rate of 1ml/min has resulted in the development of a brand-new, effective, and exact high performance liquid chromatographic method. Acetonitrile and buffer are mixed in 60:40 ratios for the mobile stage, and the buffer is created by dissolving 1 mL of formic acid in 1 liter of HPLC water. The detection was done at a wavelength of 250 nm. After 8 minutes of running time, the Cidofovir and Famciclovir peaks were separated, with the former peak eluting after 2.8 minutes and the latter peak eluting after 6.4 minutes, respectively.The proposed method displays strong linearity in the concentration ranges of 7.5 g/ml to 112.5 g/ml for cidofovir and 25 g/ml to 375 g/ml for famciclovir. The findings of the precision and recovery examinations range from 98 to 102%. The percent RSD is less than 2.0% in any robustness scenario. Under pressure, deterioration has little impact, and solutions remain effective for the entire day. The parameters of precision, accuracy, specificity, stability, robustness, linearity, limit of detection, and limit of quantification were evaluated and found to be within the acceptable range when the method was devised and validated in accordance with ICH guidelines.
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