CH. Naveen Kumar*, V. Madhavilatha,A. Rajani, Vijaya Kuchana
Department of Pharmaceutical Analysis & Quality Assurance, Teegala Krishna Reddy College of Pharmacy, Meerpet, Saroornagar, Hyderabad, Telangana, India.
A simple, reliable, sensitive and isocratic stability indicating reversed phase high performance liquid chromatography (RP-HPLC) method was developed and validated for the determination of assay of Famciclovir in Famciclovir drug substance. The paper describes method development, optimization and validation of an isocratic HPLC method for the assay of Famciclovir. The separation was achieved on Zorbax SB C8, 250mm×4.6mm, 5μm particle diameter column. The mobile phase consisted of phosphate buffer (pH: 4.0±0.05 with dilute orthophosphoric acid) and Acetonitrile 65:35 (v/v)); with flow rate of 1.0 mL min-1 at ambient temperature. The analyte was monitored by photodiode array detector at 220 nm. The drug substance was subjected to stress conditions of hydrolysis, oxidation, photolysis, thermal and humidity degradation. The peak purity was determined by PDA detector using waters empower pro software. A linear response was observed over the concentration range from 20 – 30 μg mL-1 with correlation coefficient value 0.9999. The average recovery is 99.9%. The relative standard deviation (R.S.D) for intra-day and inter-day was 0.2% and method is robust in all varied conditions. The sample solution was stable for 24 hours at ambient temperature. The results proves that method was suitable for the determination of assay of Famciclovir and successfully applied for routine analysis of Famciclovir drug substance.
Keywords: Famciclovir, Assay method, HPLC, Stability indicating method.