Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDIATING RPHPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF LEVOFLOXACIN HEMIHYDRATE AND ORNIDAZOLE IN COMBINED DOSAGE FORM

Shweta B. Pednekar* and Sachi S. Kudchadkar

Abstract

A simple, accurate, sensitive and robust reversed-phase high performance liquid chromatographic (RP-HPLC) coupled with degradation study for the simultaneous determination of Levofloxacin Hemihydrate and Ornidazole has been developed. The method was performed with a Thermo scientific Grace RP-C 18 column (250 mm x 4.6 i.d., 5μ particle size) and a UV detector, using Methanol: 0.02 mol/L Phosphate buffer pH 3.0 (50:50% v/v) as the mobile phase at flow rate of 1.0 mL/min and detection wavelength at 310 nm. The run time of the method was set at 10 mins. The retention time of Levofloxacin Hemihydrate and Ornidazole in the chromatogram was recorded at 4.42±0.5 min and Ornidazole at 5.57±0.5 min respectively. Calibration curve indicated linearity range from 5- 40 μg/mL for Levofloxacin Hemihydrate and 10 -80 μg/mL for Ornidazole respectively. The mean recovery was found to be in the range from 100.10-102.20% for Levofloxacin Hemihydrate and 98.54-102.54 % for Ornidazole. To establish the stability of the method and the drug solutions degradation study was carried out in acid, base, oxidation, thermal and photolytic study in UV chamber and the percent degradation was calculated. As this method could effectively separate the drug from its degradation products, it can be used as the stability indicating method.

Keywords: Levofloxacin Hemihydrate, Ornidazole, RP-HPLC.