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ABSTRACT:
Objective: A new reversed-phase High Pressure Liquid Chromatographic (RP-HPLC) method was developed for the determination of Esomeprazole and Itopride based on isocratic elution using a mobile phase consisting of Di- Potassium hydrogen phosphate buffer [pH 7.29] and Methanol [HPLC Grade] (60:40, v/v) at a flow rate of 1 ml min-1. The chromatographic separation was achieved on a Agilent ZorebaxC18 column (150 mm × 4.6 mm, 5 µm). Method: The run time was maintained for 10mins. The Inter day and intraday precision was found to be within the limits. The Accuracy values were within specified limits (98-102%). Result: The Limit of Detection for Esomeprazole and Itopride was found to be 2.9814 and 2.941 µg/ml respectively. The Limit of Quantification for Esomeprazole and Itopride was found to be 9.9379 and 9.804 µg/ml respectively. Conclusion: The proposed method was adequate sensitive, reproducible, and specific for the determination of Esomeprazole and Itopride bulk as well as in its capsules dosage forms. The validation of method was carried out utilizing ICH-guidelines. The described HPLC method was successfully employed for the analysis of pharmaceutical formulations containing combined dosage form. The peak homogeneity data for the drugs Esomeprazole and Itopride were obtained by using Photodiode Array detector in the stressed sample chromatograms which demonstrated the specificity of the method for the estimation in the presence in the presence of degradants. The present work was undertaken with the aim to develop and validate a rapid and consistent stability indicating RP-HPLC in which the peaks will be appear with short period of time as per ICH Guidelines. The proposed method was simple, fast, Accurate and precise method for the Quantification of drug in the dosage form, bulk drug as well as for routine analysis in Quality control. Overall the proposed method was found to be suitable and Accurate for the Quantitative determination and stability study of the drug in Pharmaceutical dosage form.
KEYWORDS: Esomeprazole, Itopride, RP-HPLC, ICH Guideline, Validation, LOD, LOQ, Accuracy, Precision.
(ProQuest: ... denotes formula omitted.)
INTRODUCTION:
Esomeprazole magnesium [bis (5-methoxy-2-[(S)-[(4- methoxy-3, 5- dimethyl-2-pyridinyl) methyl] sulfinyl]-1-Hbenzimidazole- 1-yl) magnesium salt] is a compound that inhibits gastric acid secretion. Esomeprazole (fig.no.1) is cost effective in the treatment of gastric oesophageal reflux diseases.
Esomeprazole is the S-isomer of Omeprazole, the first single...