Development and validation of RP-HPLC method for quantitative estimation of related substances in gatifloxacin drug substance

Alladi Devi  Sravanthi; Ponnuri Bharath; Peddi  Kiranmayi; Dittakavi Ramachandran

doi:10.62638/ZasMat1148

Zaštita Materijala (Jun 2024)

Development and validation of RP-HPLC method for quantitative estimation of related substances in gatifloxacin drug substance

Alladi Devi Sravanthi,
Ponnuri Bharath,
Peddi Kiranmayi,
Dittakavi Ramachandran

Affiliations

Alladi Devi Sravanthi: Acharya Nagarjuna University, Department of Biochemistry, Nagarjuna Nagar, Guntur. Andhra Pradesh, India
Ponnuri Bharath: Acharya Nagarjuna University, Department of Chemistry, Nagarjuna Nagar, Guntur. Andhra Pradesh, India
Peddi Kiranmayi: Acharya Nagarjuna University, Department of Biochemistry, Nagarjuna Nagar, Guntur. Andhra Pradesh, India
Dittakavi Ramachandran: Acharya Nagarjuna University, Department of Chemistry, Nagarjuna Nagar, Guntur. Andhra Pradesh, India

DOI: https://doi.org/10.62638/ZasMat1148
Journal volume & issue: Vol. 65, no. 2
pp. 191 – 201

Abstract

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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.

gatifloxacin, determination of related substances, liquid chromatography

Published in Zaštita Materijala

ISSN: 0351-9465 (Print); 2466-2585 (Online)
Publisher: Engineering Society for Corrosion, Belgrade
Country of publisher: Serbia
LCC subjects: Technology: Chemical technology
Website: https://www.zastita-materijala.org/

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