Development and validation of stability indicating HPLC method for quantification of tinidazole
Randa Bakheet Ahmed (1,*) , Mohamed El-Muktar Abdelaziz (2) , Ahmed Elsadig Mohammed Saeed (3)
(1) Azal Pharma Laboratories, Khartoum, 11111, Sudan
(2) Department of Chemistry, College of Science, Sudan University of Science and Technology, Khartoum, 11111, Sudan
(3) Department of Chemistry, College of Science, Sudan University of Science and Technology, Khartoum, 11111, Sudan
(*) Corresponding Author
Received: 05 Nov 2018, Accepted: 12 Dec 2018, Published: 30 Jun 2019
A simple, precise, reproducible and economical HPLC method for estimation of tinidazole has been developed. The wavelength of 317 nm is selected as λmax 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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