World Journal of
Pharmaceutical and Life Sciences

METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF PRULIFLOXACIN IN BULK FORM AND TABLET DOSAGE FORM BY RP-HPLC

C. Pooja*, K. Sujatha and A. Yasodha

ABSTRACT

A new, economical, simple, rapid, precise, accurate and reproducible RP-HPLC method for determination of Prulifloxacin in bulk form and marketed pharmaceutical formulation. Separation of Prulifloxacin was successfully achieved on a Symmetry ODS (C18) RP Column, 250 mm x 4.6 mm, 5μm column in an isocratic mode of separation utilizing Phosphate Buffer: Methanol in the ratio of 46:54% v/v (pH-3.2) at a flow rate of 1.0mL/min and the detection was carried out at 206nm. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision, specificity and robustness. The response was found to be linear in the drug concentration range of 0-140mcg/mL for Prulifloxacin. The correlation coefficient was found to be 0.9993 for Prulifloxacin. The LOD and LOQ for Prulifloxacin were found to be 0.08μg/mL and 0.24μg/mL respectively. The proposed method was found to be good percentage recovery for Prulifloxacin, which indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard solution with the sample solution. Therefore, the proposed method specifically determines the analyte in the sample without interference from excipients of pharmaceutical dosage forms.

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