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ISSN 2063-5346
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METHOD DEVELOPMENT, VALIDATION AND STABILITY INDICATING STUDIES OF TINIDAZOLE IN ITS API AND FORMULATION BY USING UV-SPECTROSCOPIC AND RPHPLC METHODS

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L Siva Sanker Reddy1*, A Keerthi2 , R Nageswara Rao3 , N Madana Gopal4 , Shaik Muneer5 , G Harsitha6 , K Subbalakshmi7 , K Kalavathi8 , Ayesha Dudekula9 , G Himaja10, K Maheswari
» doi: 10.48047/ecb/2023.12.si5a.0407

Abstract

The main objective of this project is to develop and validate a simple, precise and accurate method by using UV-Spectroscopic and RP-HPLC methods. Tinidazole is an antibiotic used for bacterial infections and parasitic infections, which is caused by Trichomonas vaginalis, Entamoeba histolytica. It is soluble in organic solvents such as ethanol, DMSO, dimethyl formamide, sparingly soluble in aqueous buffers. Its pka value is 4.70. From the literature review, the solvents used are methanol: buffer; acetonitrile: water: methanol; methanol were the mobile phases. Column C18 (4.6×250mm); 5µm. The λmax was found at 315nm for the drug whose mobile phase was finalised as acetonitrile: 0.1% IPA-90:10 after performing different trials. System suitability parameters that included retention time (2.689 min), area (430651), number of theoretical plates (4355), tailing factor (1.012) found to be within limits. Linearity range was from 10µg/ml to 50µg/ml and the regression value was 0.9919. Accuracy and precision were within the limits. Robustness studies were performed. LOD and LOQ values were 1.4µg/ml and 4.8µg/ml respectively. Degradation studies were also performed and was found to be within the limits. It is a simple and less economical method as the Retention time was 2.6min which is less compared to other methods. A simple, precise, accurate method was developed and validated according to ICH Q2R1 guidelines

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