Validated Stability-indicating assay method for determination of Ilaprazole in bulk drug and tablets by high performance liquid chromatography

Abstract

A validated stability-indicating HPLC method has been reported for the determination of Ilaprazole in
bulk drug and tablet. The drug was subjected to the various stress conditions as per the ICH
guidelines. The degradation behavior of Ilaprazole was studied under hydrolytic, oxidative, photolytic
and thermal conditions and was found to be unstable in almost all conditions except under alkaline and
photolytic conditions. The separation of drug and its degraded products was carried out on Kinetex C18 100A (5µ, 250×4.6 mm) column. The initial mobile phase composition used was Acetonitrile and
water in the ratio 50:70v/v for 1 min then changed to 70:30v/v in next 6 min and finally equilibrated
back to initial composition in 14min. The method was applied for the determination of Ilaprazole in
marketed tablet formulation. The detection was carried at 305 nm using PDA detector with a flow rate
of 1.0ml/min and injection volume 20µl. The validation of developed method was performed for
linearity, accuracy, precision, selectivity and specificity and robustness