ISSN : 2348 - 8948

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Volume : 5 Issue :7 Month : July (2017)
Page Numbers : 249-255

RP-HPLC Method Development and Validation of Pazufloxacin in their Bulk and formulation

Kandarp M. Patel, B.N.Suhagia
The present work was the development of a simple, efficient, and reproducible reverse-phase high performance liquid chromatographic (RP-HPLC) method for determination of Pazufloxacin (PFX) in bulk and its injection dosage form. The solvent system and wavelength were optimized in order to maximize the sensitivity of the proposed method and detection wavelength was carried out at 249 nm. The separation was achieved on HPLC binary gradient system equipped with HPLC 3000 series UV detector and Agilent Zorbax column C18 (4.6mm50mm5m). The optimized mobile phase composition was methanol: phosphate buffer pH 4 (50:50%v/v). The separation of PFX was carried out on Kromasil C-18 (250 4.6 mm5 𝜇m) column using phosphate buffer pH 4 and methanol by linear gradient program. Flow rate was 1.0 ml/min with a column temperature of 30ᵒC. The method was validated in terms of accuracy, precision, linearity, LOD & LOQ of sample solution as per ICH guidelines. Linearity was observed in the concentration range of 5-25 μg/ml & gave mean correlation coefficient 0.998. The developed RP-HPLC method was found to be accurate, precise and was successful applied to a Pazufloxacin bulk powder and its marketed formulation for qualitative estimation of Pazufloxacin.
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