Analytical Method Development and Validation of High-Performance Liquid Chromatography for Simultaneous Determination of Oxytetracycline Hydrochloride and Flunixin in Veterinary Injectable Solution

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Date
2021-08-26
Authors
Rand Abdullah
Aseel Mansour
Mais Mansour
Naser Shraim
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Abstract
A linear, precise, specific and accurate high performance liquid chromatographic validation method was developed for determination of Oxytetracycline and Flunixine in an injectable pharmaceutical dosage form (Fenox®). The purpose of high performance liquid chromatography (HPLC) analysis of any drug is to confirm the identity of a drug and provide quantitative results and also to monitor the progress of the therapy of a disease. The aim of the study is to develop and validate a liquid chromatographic method to quantify and determine two active ingredients simultaneously in one dosage form. The proposed method is rapid, cost-effective and can be used as a quality-control tool for routine quantitative analysis of these two active ingredients in the injectable dosage form. The HPLC analysis was performed on the phenomixc18, 15cm column, which was of a diameter of 4.5 mm and a particle size of 5 µm. Different mobile phases were then tested by using different mixture of ACN and buffer solution to obtain a suitable retention time and a pH 8.5. The UV detection was performed at the wavelength (λmax) range of 200-500 nanometers and the retention time of ocytetracycline 1.343 and flunixine 4.573 min. Analytical method validation was done in accordance to ICH guidelines. The linearity of the calibration curve was then established in the concentration range of 0.16-0.64 mg\ml of Oxytetracycline and 0.032-0.128 mg/ml of Flunixine. The mean recovery of 101.4 % -100.2%. The values of LOD Oxytetracycline 0.011949 flunixine 0.005281 and LOQ oxytetracycline 0.036209 flunixine 0.016003. According to the accuracy outcome results the RSD value for all Oxytetracycline samples is 0.283841 and for Flunixine samples is 0.304195, which represents good accuracy of the used method. As well the developed method showed excellent linearity, accuracy, precision, specificity, robustness, LOD and LOQ results within the acceptance criteria.
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