Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Fosamprenavir Calcium in Pure and Pharmaceutical Dosage Forms

摘要

The main objective is to develop a simple, specific, accurate, precise and stability-indicating RP-HPLC method for the estimation of fosamprenavir calcium in pure and tablet dosage form. The optimized method uses a reverse phase column, Inettsil C8- 3 (250 mm x 4.6 mm x 5 μm) HPLC column in isocratic mode employing buffer (ammonium formate and triethylamine pH 3.2 ± 0.05) and solvent mixture (methanol:acetonitrile 60:40) in the ratio 60:40 (v/v) with a flow rate of 1.0 mL min~(-1). Detector wavelength was monitored at 266 nm and column temperature was maintained at 30 °C.The developed method resulted in fosamprenavir calcium eluting at 4.1 min. The developed method was validated according to International Conference on Harmonization (ICH) guidelines. Fosamprenavir calcium exhibited linearity in the range of 22.4-134.4 μg/mL. The relative standard deviation for both intra-day and inter-day precision was found to be not more than 1 %. Percentage mean recovery was found to be in the range of 100 to 101 %, during accuracy studies. Degradation studies are performed under various conditions like acid, alkali, peroxide and photolytic. Where better resolution was achieved for the analyte peak from the degradants and in each condition it was found that purity threshold value was greater than the angle value hence the peak is said to be pure. These results are proved that the method would have great value when used for the analysis of commercial samples economically.