Abstract:
The present work involves the development and validation of a simple, accurate and
precise UV spectrophotometric method and RP-HPLC Method for the assay of Ilaprazole.
Simple, specific, accurate, precise and reproducible method have been developed and
validated for the estimation of Ilaprazole in its tablet dosage form.
UV- spectrophotometric method was a determined at 306nm over the concentration range
5-50μg/ml for Ilaprazole in 0.1 N NaOH. The % recovery of the drug (in sample
preparation) was found to be 99.52-100.82%.
The RP-HPLC method was developed and validated for Ilaprazole in its tablet dosage
Form. The method was performed on a Hypersil BDS C18 (250mm X 4.6 mm i.d., 5 μm
particle size) with a gradient system of (Water: Acetonitrile) in the ratio of (30:70 v/v).
The mobile phase at a flow rate of 1.0 ml/min, Injection volume 20μl and wavelength of
detection used was 306nm. The retention time for Ilaprazole was obtained as 4.957min.
The linearity of the proposed method was investigated in the range of 5-25μg/ml. Correlation coefficient was 0.9983 for Ilaprazole. The developed method was validated as
per ICH guideline, for its accuracy, precision, LOD & LOQ and the results were found to
be satisfactory, thus the method is specific, rapid and simple with good sensitivity for
estimation of Ilaprazole. These analytical methods are also applicable in ordinary
laboratories. It can also be adopted for quality control tests for these drugs in tablets.