Development and validation of stability indicating HPLC method for quantification of tinidazole

Randa Bakheet Ahmed; Mohamed El-Muktar Abdelaziz; Ahmed Elsadig Mohammed Saeed

doi:10.5155/eurjchem.10.2.102-107.1813

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Published: Jun 30, 2019

DOI: https://doi.org/10.5155/eurjchem.10.2.102-107.1813

Keywords:

HPLC, Validation, Tinidazole, Factorial design, Stability indicating, Method development

Section

Research Article

Issue

Vol. 10 No. 2 (2019): June 2019

Dates

Received 2018-11-05
Accepted 2018-12-12
Published 2019-06-30

Randa Bakheet Ahmed

Azal Pharma Laboratories, Khartoum, 11111, Sudan

http://orcid.org/0000-0001-9030-3838

Mohamed El-Muktar Abdelaziz

Department of Chemistry, College of Science, Sudan University of Science and Technology, Khartoum, 11111, Sudan

http://orcid.org/0000-0003-4426-5708

Ahmed Elsadig Mohammed Saeed

Department of Chemistry, College of Science, Sudan University of Science and Technology, Khartoum, 11111, Sudan

http://orcid.org/0000-0002-7317-8040

Abstract

A simple, precise, reproducible and economical HPLC method for estimation of tinidazole has been developed. The wavelength of 317 nm is selected as λ_max for tinidazole in phosphate buffer (pH = 6.8). Validation parameters were tested following International Conference on Harmonization (ICH) guideline. Tinidazole shows linearity at the selected wavelength and obeys Beer’s law in the concentration range of 3.2-40.0 µg/mL with correlation coefficient of 0.9999. Recovery studies for tinidazole were performed and the percentage recovery was obtained in the range of 99.10-102.45% confirming the accuracy of the proposed method. The method showed good reproducibility and recovery with %RSD less than 2. Statistical validation of the data shows that the proposed method can be used as stability indicating method which successfully applied for the routine analysis of drug in commercial tablets.

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How to Cite

(1)

Ahmed, R. B.; Abdelaziz, M. E.-M.; Saeed, A. E. M. Development and Validation of Stability Indicating HPLC Method for Quantification of Tinidazole. Eur. J. Chem. 2019, 10, 102-107.

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Supporting Agencies

Azal Pharma Laboratories, Khartoum, Sudan

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