[Development and validation of stability indicating RP-HPLC methods for determination of fosinopril in raw material and tablets]

ABSTRACT

The effective angiotensine converting enzyme inhibitors Fosinopril is widely used in the treatment of hypertension and congestive heart failure. Four specific sensitive and rapid RP-HPLC methods have been developed for assaying Fosinopril in raw material and in tablets. The assay was performed using C18 and C8 columns and mobile phases consisting of acetonitrile, methanol and buffer [10mM potassium phosphate, adjusted to pH 2.5 using orto phosphoric acid]. The flow rate was 1 ml/min and the analyte was determined using UV detector at 220 nm. The assay methods were validated [Linearity, Accuracy, Precision, Specificity, Robustness, Limit of detection, Limit of quantification], all validation parameters were found to be within the acceptance range. Stress conditions were applied to the tested drug according to ICH guidelines. The drug was found to undergo extensive degradation in basic solutions, light and high temperature conditions, whereas, the extent of degradation was found to be lower in acidic medium and in presence of oxidizing agents. The developed analytical procedures were able to separate the drug from its degradation products, and they were all stability indicating methods: