Stability Indicating UV Spectrophotometric Method for Estimation of Omeprazole and Its Application to Content Uniformity Testing

Abstract

Omeprazole is a most commonly used antiulcer agent in clinical practices. A least time consuming efficient and simple ultraviolet spectrophotometric method for the assay of omeprazole has been developed. The assay was based on the ultraviolet absorbance maxima at about 217.80 nm wavelength of omeprazole using sodium hydroxide as the solvent. In the present study comprehensive stress degradation was carried out according to ICH Q1 (R2) guidelines. The drug was subjected to acidic (0.1N HCl), basic (0.1N NaOH), oxidative (1% H2O2), photolytic and thermal degradation conditions. The developed UV spectrophotometric method showed high degradation under acidic condition, moderate degradation under basic, photolytic and thermal conditions. But it was relatively stable under oxidative conditions. The pathway for degradation has been proposed. The method was validated for Linearity, Accuracy, Precision, Specificity, Ruggedness and Robustness. The method shows good linearity in the range of 2-20μg/ml. The LOD and LOQ were found to be 0.1 μg/ml and 1.1 μg/ml. The %RSD was found to be with in limit i.e. less than 2%.The mean recovery of placebo was 100.68%. It can be concluded that the developed procedure is valid and can be applicable for determination of content uniformity for available brands of omeprazole. This method is applicable for the daily routine quality control quantitative analysis of omeprazole.