Development and validation of RP-HPLC method for quantitative estimation of related substances in gatifloxacin drug substance
The analysis of improved RP-HPLC method for the separation and quantification of Gatifloxacin and its impurities are described. Samples are analysed by means of reverse phase (RP-HPLC) using an Zorbax Eclipse C18, 50 x 4.6 mm5µm and the mobile phase consists of two Channels A and B.Channel-A:0.1% Tr...
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| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Engineering Society for Corrosion, Belgrade
2024-06-01
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| Series: | Zaštita Materijala |
| Subjects: | |
| Online Access: | https://www.zastita-materijala.org/index.php/home/article/view/1148 |
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| Summary: | The analysis of improved RP-HPLC method for the separation and quantification of Gatifloxacin and its impurities are described. Samples are analysed by means of reverse phase (RP-HPLC) using an Zorbax Eclipse C18, 50 x 4.6 mm5µm and the mobile phase consists of two Channels A and B.Channel-A:0.1% Trifluoroacetic acid buffer and Channel-B:Acetonitrile. The flow rate is 1.0 ml/min. The column temperature was maintained at 35°C and sample temperature was maintained at 25°C, injection volume 10µLand wavelength fixed at 220nm UV-detection. The developed LC method was validated with respect to specificity, precision, linearity, ruggedness and robustness. Validation study compared as per ICH guideline. |
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| ISSN: | 0351-9465 2466-2585 |