Convenient estimation of oxytetracycline and polymyxin B by a novel high-performance liquid chromatography method: development and validation

Aim: The aim of this research work was to develop a validated reversed-phase (RP)-high-performance liquid chromatography (HPLC) method for simultaneous estimation of oxytetracycline (OXY) and polymixin B (PMB) in fixed-dose combination. Methods: The HPLC assay method was validated on X-Bridge C18 [2...

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Main Authors: Tanu Chaudhary, Balak Das Kurmi, Dilpreet Singh
Format: Article
Language:English
Published: Open Exploration 2023-02-01
Series:Exploration of Drug Science
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Online Access:https://www.explorationpub.com/uploads/Article/A10082/10082.pdf
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author Tanu Chaudhary
Balak Das Kurmi
Dilpreet Singh
author_facet Tanu Chaudhary
Balak Das Kurmi
Dilpreet Singh
author_sort Tanu Chaudhary
collection DOAJ
description Aim: The aim of this research work was to develop a validated reversed-phase (RP)-high-performance liquid chromatography (HPLC) method for simultaneous estimation of oxytetracycline (OXY) and polymixin B (PMB) in fixed-dose combination. Methods: The HPLC assay method was validated on X-Bridge C18 [250 mm × 4.6 mm intradermal (i.d.), 5 μm], mobile phase consisting of aotearoa co-incidence network (ACN):water containing 0.5% (v/v) orthophosphoric acid (pH 3.5) in the ratio of 80:20 respectively. The flow rate was set at 0.9 mL/min and the column was maintained at room temperature. The RP-HPLC method was validated in terms of the calibration curve (CC), linearity and range, limit of detection (LOD), and limit of quantitation (LOQ), precision, robustness, and accuracy. Results: The method was found to be linear with a concentration range of 5–25 μg/mL. Precision results showed the developed method was found to be precise with a relative standard deviation [RSD (%)] value < 2. Accuracy showed acceptable recovery of prepared concentrations as per International Conference on Harmonization (ICH) guidelines. Moreover, the developed method was found to be robust and rugged, as per specified ranges. The assay of these two drugs in marketed formulation, i.e., Terramycin® Ointment showed satisfactory recovery, as per ICH guidelines. The results proved that the method can be used for the routine-based estimation of OXY and PMB. Conclusions: Linear CC were obtained with a correlation coefficient (R2 > 0.99) with acceptable results of accuracy and precision. Graphical abstract.Ultraviolet visible and HPLC method development
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institution Kabale University
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spelling doaj-art-979afe78864340fbb44bd940544f1c762025-02-08T04:48:16ZengOpen ExplorationExploration of Drug Science2836-76772023-02-01161710.37349/eds.2023.00002Convenient estimation of oxytetracycline and polymyxin B by a novel high-performance liquid chromatography method: development and validationTanu Chaudhary0https://orcid.org/0000-0002-9044-2886Balak Das Kurmi1https://orcid.org/0000-0001-8470-6622Dilpreet Singh2https://orcid.org/0000-0002-7563-6287Department of Quality Assurance, ISF College of Pharmacy, Moga, Punjab 142001, IndiaDepartment of Pharmaceutics, ISF College of Pharmacy, Moga, Punjab 142001, IndiaDepartment of Pharmaceutics, ISF College of Pharmacy, Moga, Punjab 142001, IndiaAim: The aim of this research work was to develop a validated reversed-phase (RP)-high-performance liquid chromatography (HPLC) method for simultaneous estimation of oxytetracycline (OXY) and polymixin B (PMB) in fixed-dose combination. Methods: The HPLC assay method was validated on X-Bridge C18 [250 mm × 4.6 mm intradermal (i.d.), 5 μm], mobile phase consisting of aotearoa co-incidence network (ACN):water containing 0.5% (v/v) orthophosphoric acid (pH 3.5) in the ratio of 80:20 respectively. The flow rate was set at 0.9 mL/min and the column was maintained at room temperature. The RP-HPLC method was validated in terms of the calibration curve (CC), linearity and range, limit of detection (LOD), and limit of quantitation (LOQ), precision, robustness, and accuracy. Results: The method was found to be linear with a concentration range of 5–25 μg/mL. Precision results showed the developed method was found to be precise with a relative standard deviation [RSD (%)] value < 2. Accuracy showed acceptable recovery of prepared concentrations as per International Conference on Harmonization (ICH) guidelines. Moreover, the developed method was found to be robust and rugged, as per specified ranges. The assay of these two drugs in marketed formulation, i.e., Terramycin® Ointment showed satisfactory recovery, as per ICH guidelines. The results proved that the method can be used for the routine-based estimation of OXY and PMB. Conclusions: Linear CC were obtained with a correlation coefficient (R2 > 0.99) with acceptable results of accuracy and precision. Graphical abstract.Ultraviolet visible and HPLC method developmenthttps://www.explorationpub.com/uploads/Article/A10082/10082.pdfoxytetracyclinpolymixin bvalidation high-performance liquid chromatography analysisanalysis
spellingShingle Tanu Chaudhary
Balak Das Kurmi
Dilpreet Singh
Convenient estimation of oxytetracycline and polymyxin B by a novel high-performance liquid chromatography method: development and validation
Exploration of Drug Science
oxytetracyclin
polymixin b
validation high-performance liquid chromatography analysis
analysis
title Convenient estimation of oxytetracycline and polymyxin B by a novel high-performance liquid chromatography method: development and validation
title_full Convenient estimation of oxytetracycline and polymyxin B by a novel high-performance liquid chromatography method: development and validation
title_fullStr Convenient estimation of oxytetracycline and polymyxin B by a novel high-performance liquid chromatography method: development and validation
title_full_unstemmed Convenient estimation of oxytetracycline and polymyxin B by a novel high-performance liquid chromatography method: development and validation
title_short Convenient estimation of oxytetracycline and polymyxin B by a novel high-performance liquid chromatography method: development and validation
title_sort convenient estimation of oxytetracycline and polymyxin b by a novel high performance liquid chromatography method development and validation
topic oxytetracyclin
polymixin b
validation high-performance liquid chromatography analysis
analysis
url https://www.explorationpub.com/uploads/Article/A10082/10082.pdf
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AT balakdaskurmi convenientestimationofoxytetracyclineandpolymyxinbbyanovelhighperformanceliquidchromatographymethoddevelopmentandvalidation
AT dilpreetsingh convenientestimationofoxytetracyclineandpolymyxinbbyanovelhighperformanceliquidchromatographymethoddevelopmentandvalidation