Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC-UV ANALYTICAL METHOD FOR QUANTITATIVE DETERMINATION OF METRONIDAZOLE

Kashif Ali Safdar*, S. Baqir S. Naqvi, Shahnaz Gauhar, Abdullah Jabbar

ABSTRACT

The aim of the present study was to develop a simple, rapid and sensitive reversed-phase high performance liquid chromatographic (RH-HPLC) analytical method for the quantitative determination of metronidazole in pharmaceutical dosage form. Metronidazole is a nitroimidazole antibiotic medication used particularly for anaerobic bacteria and protozoa.. The chromatographic separation was carried out on Shimadzu prominence series 20-A apparatus equipped with autosampler, degassing unit and built-in cooler by using Hibar® C18 RP column (250mm X 4.6mm, 5µm) as stationary phase and 0.01M potassium dihydrogen phosphate (pH 3.0) and acetonitrile (83:17, V/V) as mobile phase at 1.0 mL/minute flow rate. The UV detection was carried out at 320nm. The method was validated as per the ICH guideline for Validation of Analytical Procedures Q2(R1) and found to be specific without interferences from mobile phase components and impurities. The method was linear over the range of 10µg/mL to 30µg/mL (r2 = 0.9999) with adequate level of accuracy and precision. The method has shown acceptable level of robustness with repeatability, reproducibility and intermediate precision. The proposed method can be confidently employed with adequate level of assurance for the routine testing of metronidazole in pharmaceutical dosage form.

Keywords: Metronidazole, RP-HP Analytical Method, Validation by ICH.