Development of High Performance Liquid Chromatography (HPLC) Method for the Estimation of Fosamprenavir Calcium in Pharmaceutical Formulation

A Novel, rapid, precise, accurate and stability indicating High Performance Liquid Chromatography (HPLC) method was developed for quantitative analysis of Fosamprenavir Calcium in tablet formulation. Detection of Fosamprenavir calcium in the presence of degradation products was achieved on X-Bridge C18, (250 X 4.6 mm, 5μ) column at 30 °C using a mixture of Phosphate Buffer (pH 6.8 ± 0.05) and Acetonitrile in the proportion 70:30, v/v as the mobile phase. A PDA detector set at 265 nm was used for detection. The peak for Fosamprenavir calcium was observed at 7.97 minute. A linear response was observed in the range of 50-150 μg/mL with a correlation coefficient of 0.9991. The investigated validation parameters showed that the method is specific, accurate, precise and robust. The method can be used for routine quality control analysis of Fosamprenavir calcium drug substance. The method was validated as per ICH guideline.