METHOD DEVELOPMENT AND VALIDATION OF EPROSARTAN MESYLATE AND ITS IMPURITIES USING REVERSE PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY


O. S. S. Chandana, D. Sathis Kumar, R. Ravichandra Babu

Abstract


Objective: Our main objective is to develop an accurate and precise RP-HPLC method for the determination of Eprosartan Mesylate and its impurities.

Methods: A Develosil ODS UG-5; (150 × 4.6) mm; 5 µm column was used for the Separation of drugs by a mobile phase consisting of Buffer and Acetonitrile mixture in the gradient proportion. The flow rate maintained was 0.8 ml/min and the wavelength used for detection was 235 nm.

Results: The linearity was observed in the range of 0.025-50µg/ml of spiked impurities in Eprosartan Mesylate, impurity 1 and impurity 2 with a correlation coefficient of 0.99927, 0.99910 and 0.99934 respectively. The mean percentage recoveries for LOQ, 50%, 80%, 100%, 150% and 200% accuracy were found to be 101.5±1.51, 107.0±1.7, 104.6±0.4, 102.8±0.36, 101.7±0.26 and 101.3±0.15 respectively for impurities in Eprosartan Mesylate, impurity 1 and impurity 2. Linearity, accuracy, precision and robustness parameters for the suggested method were estimated for validation.

Conclusion: The developed method is uncomplicated, accurate, sensitive and precise for the determination of related substances in the Eprosartan Mesylate. The satisfying % recoveries and low % RSD Values confirmed the suitability of the developed method for the usual analysis of Eprosartan mesylate in pharmaceuticals.

Keywords


Eprasartan impurities, HPLC, Method Development, Validation, Forced degradation studies

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About this article

Title

METHOD DEVELOPMENT AND VALIDATION OF EPROSARTAN MESYLATE AND ITS IMPURITIES USING REVERSE PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

Keywords

Eprasartan impurities, HPLC, Method Development, Validation, Forced degradation studies

DOI

10.22159/ijcpr.2016v8i4.15277

Date

18-10-2016

Additional Links

Manuscript Submission

Journal

International Journal of Current Pharmaceutical Research
Vol 8, Issue 4, 2016 Page: 49-53

Online ISSN

0975-7066

Statistics

72 Views | 73 Downloads

Authors & Affiliations

O. S. S. Chandana
Department of Chemistry, Institute of Science, Gitam University, Visakhapatnam, Andhra Pradesh, India

D. Sathis Kumar
Aditya Institute of Pharmaceutical Sciences and Research, Surampalem, Andhra Pradesh, India 533437

R. Ravichandra Babu
Department of Chemistry, Institute of Science, Gitam University, Visakhapatnam, Andhra Pradesh, India
India


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