Stability Indicating LC Assay Method for the Determination of Famciclovir in Bulk Drug and Pharmaceutical Dosage Forms
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A simple isocratic stability indicating LC method was developed and validated for the determination of famciclovir in bulk drug and pharmaceutical dosage form. A mixture of 0.05 M potassium dihydrogen orthophosphate buffer and acetonitrile (80:20 v/v) was used as mobile phase at a flow rate of 1.0 mL min−1. Hypersil BDS C18 (250 mm × 4.6 mm × 5 μm) column was used and the eluents were monitored at 220 nm. Forced degradation studies were performed for famciclovir active substance, reconstituted matrix and 500 mg tablets using the parameters like acid, base, peroxide, temperature, light, and relative humidity. Peak purity index was checked using PDA detection to demonstrate the specificity and stability indicating nature of the method. The developed method was validated for precision, ruggedness, linearity, LOD, LOQ, range, robustness and accuracy. The developed method can be used for regular quality control and stability study applications of famciclovir bulk drug and tablet dosage forms.
KeywordsColumn liquid chromatography Stability indicating method Forced degradation Method validation Famciclovir and penciclovir
The authors thank the management of the APL group for supporting and providing the samples for this work and their colleagues in APL R&D Analytical Research Division for their co-operation in carrying out this work.
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