DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF SATRANIDAZOLE FROM ITS FORMULATION

Abstract

A sensitive stability-indicating high performance liquid chromatography (HPLC) method was developed and validated for quantitative estimation of satranidazole (SAT), a new nitroimidazole with potent antiamoebic activity and accessible in market as tablet and dry syrup either alone or in combination with ofloxacin. The present study involves the development of simple, accurate, precise, reproducible reversed phase high performance liquid chromatography (RP-HPLC) method for determination of satranidazole from its formulation. Isocratic elution at a flow rate of 1.0 mL/min was employed on Hemochrom Intsil C-18 (250 mm× 4.6 mm, 5 ?m) column at 25°C. The mobile phase consists of acetonitrile: double distilled water (DDW), pH 4 adjusted with acetic acid in the ratio of 90: 10 V/V. The UV detection wavelength was 320 nm, and 20 ?L sample was injected. The retention time for SAT was about 3.9 minutes. Forced degradation studies for stability-indicating method (SIM) were conducted as per the presented conditions of ICH guidelines. The drug showed instability in alkaline and oxidation condition while it remained stable in heat, acid and photolytic conditions. According to ICH guidelines, the developed method was validated for the following parameters: linearity, accuracy, precision, specificity, robustness, limit of detection (LOD) and limit of quantification (LOQ). The method was found to be accurate, linear, precise, robust, economical and stability-indicating for analysis of the drug as well as marketed formulation.