[PDF][PDF] Method Development and Validation of Valacyclovir Related Compounds G & E in Valacyclovir by RP-HPLC

A Rohini, SA Rahaman, VSN Murthy… - International Journal …, 2013 - researchgate.net
A Rohini, SA Rahaman, VSN Murthy, TP Rao, NL Sudeepthi
International Journal of Pharmaceutical Analysis, 2013researchgate.net
ABSTRACT A gradient reversed phase liquid chromatographic (RP-LC) method has been
developed and subsequently validated for the determination of valacyclovir and its process-
related impurities (noted as: impurity G & E). Separation was achieved with a Hypersil BDS
C18 column and buffer: acetonitrile 90: 10 (pH adjusted to 3) as eluent, at a flow rate of 0.8
mL/min. UV detection was performed at 254 nm. The described method was linear over a
range of 0.254-0.762 μg/mL for impurity G, 0.2615-0.7845 μg/mL for impurity E. The …
Abstract
A gradient reversed phase liquid chromatographic (RP-LC) method has been developed and subsequently validated for the determination of valacyclovir and its process-related impurities (noted as: impurity G & E). Separation was achieved with a Hypersil BDS C18 column and buffer: acetonitrile 90: 10 (pH adjusted to 3) as eluent, at a flow rate of 0.8 mL/min. UV detection was performed at 254 nm. The described method was linear over a range of 0.254-0.762 μg/mL for impurity G, 0.2615-0.7845 μg/mL for impurity E. The accuracy of the method has been demonstrated at 3 concentration levels in the range of 50,100,150% of the specification limit and the recovery of impurities was found to be in the range of 90–110%. The method is simple, rapid, selective, and accurate and it is useful in the quality control of bulk manufacturing and pharmaceutical formulations.
researchgate.net
以上显示的是最相近的搜索结果。 查看全部搜索结果

Google学术搜索按钮

example.edu/paper.pdf
搜索
获取 PDF 文件
引用
References