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

Authors

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

DOI:

https://doi.org/10.62638/ZasMat1148

Abstract

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.

Keywords:

Gatifloxacin, determination of related substances, liquid chromatography

Supporting Agencies

The authors are grateful to the Department of Biochemistry and Department of Chemistry, Acharya Nagarjuna University, Nagarjuna Nagar, Guntur. Andhra Pradesh, India, for providing the facilities to carry this research work.

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