Famciclovir Tablets USP Monograph Method Using a Purospher™ STAR RP-8 endcapped HPLC Column and UV Detection
Sonal Shinde, Application Specialist
Introduction
Famciclovir is an antiviral drug indicated for the treatment of herpes zoster, herpes simplex virus 2 (genital herpes), herpes labialis (cold sores), etc. It is a guanosine analogue, a prodrug form of penciclovir, and marketed by Novartis under the trade name Famvir. Generics are produced by TEVA and Mylan, among others. Purospher™ STAR RP-8 endcapped HPLC columns can be used to monitor organic impurities in tablet formulations following the new USP monograph for Famciclovir Tablets. The method suitability requirements are defined by the relative standard deviation (NMT 5.0% for Famciclovir standard solution) and the chromatographic resolution between propionyl famciclovir and 6-chloro famciclovir (NLT 1.2 using the system suitability solution).
![Famciclovir Famciclovir](/deepweb/assets/sigmaaldrich/marketing/global/images/technical-documents/articles/research-and-disease-areas/pharmacology-and-drug-discovery-research/Famciclovir/Famciclovir.jpg)
The method acceptance criteria are defined by the relative retention times for Famciclovir related compound A, Famciclovir related compound B, Famciclovir, 6-Chloro famciclovir, and Propionyl famciclovir and are about 0.2, 0.5, 1.0, 1.32, and 1.35, respectively. This application note illustrates with required analytical data that the method meets USP41-NF36 guidelines.
![Chromatographic data – blank Chromatographic data – blank solution.](/deepweb/assets/sigmaaldrich/marketing/global/images/technical-documents/articles/research-and-disease-areas/pharmacology-and-drug-discovery-research/chromatographic-data-blank/chromatographic-data-blank.jpg)
Figure 1. Chromatographic data – blank & standard solution.
![Chromatographic data – standard Chromatographic data – standard solution.](/deepweb/assets/sigmaaldrich/marketing/global/images/technical-documents/articles/research-and-disease-areas/pharmacology-and-drug-discovery-research/chromatographic-data-standard/chromatographic-data-standard.jpg)
![Chromatographic data - system suitability test (SST) solution. Chromatographic data - system suitability test (SST) solution.](/deepweb/assets/sigmaaldrich/marketing/global/images/technical-documents/articles/research-and-disease-areas/pharmacology-and-drug-discovery-research/chromatographic-data-sst-aa/chromatographic-data-sst-aa.jpg)
Figure 2.Chromatographic data - system suitability test (SST) solution.
![Chromatographic data - test solution. Chromatographic data - test solution.](/deepweb/assets/sigmaaldrich/marketing/global/images/technical-documents/articles/research-and-disease-areas/pharmacology-and-drug-discovery-research/chromatographic-data-test-solution/chromatographic-data-test-solution.jpg)
Figure 3. Chromatographic data - test solution.
2. Standard Repeatability (1 ppm)
3. Linearity, LOD & LOQ
![Concentration in ppm Concentration in ppm](/deepweb/assets/sigmaaldrich/marketing/global/images/technical-documents/articles/research-and-disease-areas/pharmacology-and-drug-discovery-research/validation-and-verification/validation-and-verification.jpg)
Figure 4.Area / Concentration in ppm
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