RP HPLC determination of famciclovir Dispersible Tablets and related substances.docVIP

 PAGE \* MERGEFORMAT 23 RP HPLC determination of famciclovir Dispersible Tablets and related substances 【Abstract】 Objective To establish a high-performance liquid chromatography separation and determination of famciclovir Dispersible Tablets and related substances. Methods Kromasil C18 (4.6mm × 250mm, 5μm) column; mobile phase: acetonitrile: 0.02mol / L potassium dihydrogen phosphate solution (25:75); flow rate: 1.0ml/min; related substances determination of detection wavelength for 220nm, HPLC detection wavelength 305nm; injection volume 20μl. The results of famciclovir concentration within the range of 29.40 ~ 88.20μg/ml peak area showed good linear relationship, r = 0.99998; average recovery was 100.1%, RSD is 0.30%, n = 9; famciclovir and its related substances can be completely separated. Conclusion The method is simple, accurate, specific and can be used for the content of dispersible tablets of famciclovir and its related substances were determined. Keywords: for Drug Control, Fujian Province, Fuzhou 350001 Determination of famciclovir and its related substances in ABSTRACT Objective To develop an RP  HPLC method for the determination of famciclovir and its related substances in famciclovir dispersible tablets. Methods The chromatographic analysis was performed on Kromasil C18 (4.6 mm × 250 mm, 5μm) column. The mobile phase consisted of acetonitrile: 0.02mol / L phosphate buffer (25:75). The flow rate was 1.0 ml / min. The detection wavelength was at 305nm for the content determination of famciclovir and it was 220nm for the analysis of its related substances, with 20 μl injection volume . Results A good linearity was obtained in the range of 29.40 ~ 88.20μg/ml (r = 0.99998). The average recovery of famciclovir was 100.1% (n = 9) with RSD 0.30%. The related substances were separated from famciclovir. Conclusion The method was simple, accurate and specific, and could be used for the quality control of famciclovir dispersible