Stability indicating HPLC method for the simultaneous quantification of aspirin and pravastatin in bulk and tablets: Method development and validation

Abstract

The aim of the present study was to develop and validate a stability indicating HPLC method for the simultaneous determination of aspirin and pravastatin in bulk and pharmaceutical dosage forms. The chromatographic separation of aspirin, pravastatin and their degradation products was achieved on Phenomex C18 column with mixture of water, acetonitrile and acetic acid (40:59:01, v/v/v) as mobile phase in an isocratic elution mode at a flow rate of 1.5 mL/min. The method exhibited linearity in the concentration range of 20.5- 61.5 μg/mL and 10-30 μg/mL for aspirin and pravastatin, respectively. The limits of detection and quantification were 0.204μg/mL and 0.680 μg/mL for aspirin and 0.077 μg/mL and 0.256 μg/mL for pravastatin, respectively. The developed method was validated with respect to accuracy, precision, selectivity, specificity and robustness. All the parameters examined were within the acceptance limits. The stability-indicating power of the proposed method was proved by subjecting the drugs to hydrolytic (acid and base), oxidative, photolytic and dry heat stress conditions. The developed method was found to be suitable for rout ine analysis of aspirin and pravastatin simultaneous in the presence of its stress degradation products.