Development and validation of analytical methods for simultaneous estimation of ofloxacin and flavoxate hcl in bulk and its tablet dosage form

Abstract

A rapid, sensitive, and specific RP-HPLC and UV Spectroscopy Method was developed and validated for simultaneous estimation of Ofloxacin and Flavoxate HCl in bulk and tablet dosage form. Spectrophotometric (Simultaneous Equation Method) and RP-HPLC were developed and validated in terms of linearity, precision, accuracy, LOD and LOQ for the simultaneous estimation of Ofloxacin and Flavoxate HCl. In Simultaneous Equation Method the linearity range was found to be 5-30 μg/ml for both the drugs. Percentage recovery for Ofloxacin was found to be in range of 99.85-101.60%, while for Flavoxate HCl, it was found to be in range of 100.40- 101.66%. LOD and LOQ values were found to be 0.78 and 2.37μg/ml for Ofloxacin and 0.99 and 3.00 μg/ml for Flavoxate HCl. RP-HPLC method was carried out on Kromasil C18(250 x 4.6mm,i.d 5μ) column using filtered and degassed mixture of ACN: Methanol: water (30:20:50 v/v) pH 3 adjusted with 0.1% TEA and ortho-phosphoric Acid as a mobile phase at a flow rate 1ml/min and effluent was monitored at 322nm. Linearity range was found to be 10- 60μg/ml for Ofloxacin and 10-60μg/ml for Flavoxate HCl. Percentage recovery for Ofloxacin was found to be in range of 99.18-99.37%, while for Flavoxate HCl, it was found to be in range of 99.33-100.08%. LOD and LOQ values were found to be 0.59 and 1.79 μg/ml for Ofloxacin and 0.90 and 2.74 μg/ml for Flavoxate HCl.