Validated Stability-indicating Assay Method For Determination Of Ilaprazole In Bulk Drug And Tablets By High Performance Liquid Chromatography | 18767
Journal of Analytical & Bioanalytical Techniques
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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 C-18 100A (5 μ, 250?4.6 mm) column. The initial mobile phase composition used was acetonitrile and water in
the ratio 50:70 v/v for 1 min then was changed to 70:30 v/v in next 6 min and finally equilibrated back to initial composition in
14 min. 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 1.0 ml/min and injection volume 20 μl. The validation of developed method
was performed for linearity, accuracy, precision, selectivity and specificity and robustness.
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