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Journal :   Research Journal of Pharmacy and Technology

Volume No. :   7

Issue No. :  2

Year :  2014

Pages :   221-228

ISSN Print :  0974-3618

ISSN Online :  0974-360X


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A New, Simple and Accurate Method Development and Validation for Simultaneous Estimation of Esomeprazole and Itopride in Pharmaceutical Dosage Form by Using RP –HPLC



Address:   S. Ashutosh Kumar1*, Arumbaka Harish1, Manidipa Debnath2, N. Sai Krishna3, J. Saravanan3, V. Greeshma3, Ch. Naga Madhusudhan Rao1
1Department of Pharmaceutical Analysis and Quality Assurance, A.K.R.G College of Pharmacy, Nallajerla, West Godavari, 534112, A.P
2Department of Pharmaceutics, A.K.R.G College of Pharmacy, Nallajerla, West Godavari, 534112, A.P
3Department of Pharmacology, A.K.R.G College of Pharmacy, Nallajerla, West Godavari, 534112, A.P
*Corresponding Author
DOI No: Not Available

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 micrometer ). 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.
Cite:
S. Ashutosh Kumar, Arumbaka Harish, Manidipa Debnath, N. Sai Krishna, J. Saravanan, V. Greeshma, Ch. Naga Madhusudhan Rao. A New, Simple and Accurate Method Development and Validation for Simultaneous Estimation of Esomeprazole and Itopride in Pharmaceutical Dosage Form by Using RP –HPLC. Research J. Pharm. and Tech. 7(2): Feb. 2014; Page221-228.
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