QbD Guided Development and Validation of RP-HPLC Method for Quantitative Estimation of Ilaprazole

The quality by design proved that new simple, sensitive, appropriate, accurate, and strongreversed-phase (RP-HPLC) method was developed and validated to determine ilaprazole inits bulk and tablet dosage form. With Central Composite Design, the chromatographiccondition was optimized. Separating was performed on Chromeleon 7.3 on Agilent ZorbaxC18 column (250 mm x 4.6mm; 5micrometer) of an HPLC system. The identifying was doneat 276 nm.The developed RP-HPLC method used the following methods: used mobile phase Phosphatebuffer: Acetonitrile in the ratio of 60:40 v/v and flow rate 1.0 mL/min and retention time wasfound to be 5.2 min. The results analysis method was verified in terms of linearity, accuracy,precision, specificity, robustness. The correlation coefficient (r2) of the developed methodwas 0.9988 and thus justified the linearity of the developed method. The accuracy of themethod RSD were less than 2.0. The percentage of recoveries of ilaprazole were found to be100.88. The proposed strategy was foreseeable and firm. The proposed method was good inpredictability and robustness.