Development and Validation of Liquid Chromatographic and UV Derivative Spectrophotometric Methods for the Determination of Famciclovir in Pharmaceutical Dosage Forms

概要

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A high-performance liquid chromatographic method and a UV derivative spectrophotometric method for the determination of famciclovir, a highly active antiviral agent, in tablets were developed in the present work. The various parameters, such as linearity, precision, accuracy, specificity, robustness, limit of detection and limit of quantitation were studied according to International Conference on Harmonization guidelines. HPLC was carried out by using the reversed-phase technique on an RP-18 column with a mobile phase composed of 50mM monobasic phosphate buffer and methanol (50:50; v/v), adjusted to pH 3.05 with orthophosphoric acid. The mobile phase was pumped at a flow rate of 1ml/min and detection was made at 242nm with UV dual absorbance detector. The first derivative UV spectrophotometric method was performed at 226.5nm. Statistical analysis was done by Student's t-test and F-test, which showed no significant difference between the results obtained by the two methods. The proposed methods are highly sensitive, precise and accurate and therefore can be used for its Intended purpose.
公益社団法人日本薬学会の論文
2006-06-01