Method Development and Validation of Gemifloxacin in Tablet Dosage Form by RP-HPLC

  • Mithun Rudrapal Sandip Institute of Pharmaceutical Sciences, Sandip Foundation, Nashik, Maharashtra, India
  • Nazim Hussain Kingston Imperial Institute of Technology and Sciences, Dehradun, Uttarakhand, India

Abstract

A simple, precise and accurate RP-HPLC method was developed and validated for the estimation of gemifloxacin in the tablet dosage form. The separation was achieved on a reversed-phase C-18 column (250 x 4.6 mm i.d., 5 µm) using a mobile phase consisting of acetonitrile/acetate buffer of pH 4.5 (70:30 v/v) at a flow rate of 1.0 ml/min and a detection wavelength of 244 nm. The separation was carried out on an isocratic mode at room temperature. The method was validated as per ICH guidelines for linearity, accuracy, precision, robustness, LOD, LOQ and specificity. The developed method showed good linearity over the concentration range of 50-150 µg/ml (r2=0.995). The average percentage recovery was 99.77%. The LOD and LOQ were 12.678 µg/ml and 14.261 µg/ml, respectively. Based upon validation studies, the developed method can be successfully applied for the routine analysis of gemifloxacin in bulk drugs as well as pharmaceutical dosage forms.


Keywords: Gemifloxacin, Tablet dosage form, RP-HPLC, Validation, ICH guidelines

Keywords: Gemifloxacin, Tablet dosage form, RP-HPLC, Validation, ICH guidelines

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Author Biographies

Mithun Rudrapal, Sandip Institute of Pharmaceutical Sciences, Sandip Foundation, Nashik, Maharashtra, India

Sandip Institute of Pharmaceutical Sciences, Sandip Foundation, Nashik, Maharashtra, India

Nazim Hussain, Kingston Imperial Institute of Technology and Sciences, Dehradun, Uttarakhand, India

Kingston Imperial Institute of Technology and Sciences, Dehradun, Uttarakhand, India

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Rudrapal M, Hussain N. Method Development and Validation of Gemifloxacin in Tablet Dosage Form by RP-HPLC. JDDT [Internet]. 15Jul.2020 [cited 3Aug.2020];10(4):97-01. Available from: http://jddtonline.info/index.php/jddt/article/view/4217