Method Development and Validation for Simultaneous Estimation of Esomeprazole and itopride Hydrochloride in Combined Pharmaceutical Dosage Form and bulk by RP-HPLC

Abstract

The developed RP-HPLC method allows rapid and precise determinations of simultaneous estimation of esmoprazole and itopride hydrochloride in combined pharmaceutical dosage forms. The objective of the proposed method is to develop simple and accurate methods for the determination of simultaneous estimation of esmoprazole and itopride hydrochloride in combined pharmacetcal dosage forms and it's stability indicative studies. A series of mobile phases were tried, among the various mobile phases, Separation of the drug was achieved on ACE C18 (150×4.6) mm, 5μ using mobile phases, (A) 6.5 pH di hydrogen ortho phosphate buffer, (B) Acetonitrile and Water in the ratio of 35: 65v/v. The flow rate was 1.2 ml/min and the detection wavelength was 272 nm. The Linearity and correlation coefficient of esomeprazole and itopride hydrochloride at 10–50μg/ml and 10–50μg/ml was found to be 0.999 and 0.999 respectively. The LOD was found to be 0.57 mg/ml and 0.56mg/ml and LOQ was found to be 1.74mg/ml and 1.69 mg/ml for Esomeprazole and itopride hydrochloride respectively which represents that sensitivity of the method is high. The method was known to be accuratewith the assay method. The % assay was found to be 99.58% and 99.98%. The developed method was showed to a good accuracy and precision. The % RSD is for Esomeprazole and itopride hydrochloride is 0.55 and 0.75. This method shows that good reproducibility of the results. Furthermore this method was simple, sensitive, and accurate. This method can be employed for routine quality control analysis of tablets of esomeprazole and itopride hydrochloride in combined pharmacetcal dosage forms in various educational institutions.