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

Abstract

Objective: To develop a simple, specific, accurate, precise and stability-indicating RP-HPLC method for estimation of acamprosate calcium in tablet dosage form. Method: The optimized method uses a reverse phase column, Inertsil ODS 3V, 250 x 4.6 mm, 5 µm mobile phase of phosphate buffer (adjusted to pH 7.0 ± 0.05 with 0.1N potassium hydroxide or 0.1% orthophosphoric acid): methanol, 95:05 v/v, at a flow rate of 1 mL/min and a detection wavelength of 205 nm using a UV detector. The developed method resulted in acamprosate calcium eluting at 3.327 min. Results: Acamprosate calcium exhibited linearity in the range of 84-504 μg/ml. The intraday and interday precision is exemplified by relative standard deviation of 0.59% and 1.58% respectively. Percentage Mean recovery was found to be in the range of 98.71-99.24%, during accuracy studies. Degradation studies were performed under various conditions where purity threshold value was found to be greater than the angle value. The analytical method was validated according to International Conference on Harmonization guidelines. Conclusion: The developed method is simple, fast, sensitive, linear, accurate, rugged and precise and hence can be applied for routine quality control of acamprosate calcium in bulk and its pharmaceutical dosage forms.