evelopment and Validation of Few UV Spectrophotometric Methods for the determination of Valganciclovir in Bulk and Pharmaceutical Dosage Form

S. Mondal, Goluguri Sunil Reddy, P. Mondal, V. Prathyusha, Aishwarya P Nair, S. Rahaman
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引用次数: 6

Abstract

Background: The present research paper described about the optimization of various zero order and first order UV spectrophotometric method using different buffers. Validation study was performed to develop a simple, sensitive, rapid, accurate and economical Ultra Violet spectrophotometric method for the estimation of Valganciclovir. Methods: UV 1800 double beam UV Visible Spectrophotometer with a pair of 10mm path length matched quartz cells were used for the study. Method A (Water), Method B (phosphate buffer pH2), Method C (Phosphate buffer pH4) and Method D (phosphate buffer pH5) were developed for estimation of Valganciclovir by zero-order and first-order derivative. Results: Linearity was carried out in the concentration range of 5-60 μg/ml and the correlation coefficient were found to be 0.999. The percentage recoveries were found to be 98-102%. The relative standard deviation was found to be <2%. The LOD and LOQ were found to be 0.3241 μg/ml and 0.8227 μg/ml respectively. Conclusion: Hence, the methods were validated according to ICH guidelines and can be adopted for the routine analysis of Valganciclovir in pure and tablet dosage form.
几种紫外分光光度法测定缬更昔洛韦原料药和制剂含量的方法的建立与验证
背景:本文研究了不同缓冲液对各种零阶和一阶紫外分光光度法的优化。为建立一种简便、灵敏、快速、准确、经济的紫外分光光度法测定缬更昔洛韦的含量进行了验证研究。方法:采用uv1800双光束紫外可见分光光度计和一对10mm径长匹配的石英细胞进行研究。建立了法A(水)、法B(磷酸盐缓冲液pH2)、法C(磷酸盐缓冲液pH4)和法D(磷酸盐缓冲液pH5)对缬更昔洛韦进行零阶导数和一阶导数估计的方法。结果:在5 ~ 60 μg/ml浓度范围内线性良好,相关系数为0.999。加样回收率为98 ~ 102%。相对标准偏差<2%。定量限和定量限分别为0.3241 μg/ml和0.8227 μg/ml。结论:该方法符合ICH指南,可用于缬更昔洛韦纯剂型和片剂剂型的常规分析。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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