Abstract :
Context: In this manuscript, a high-performance liquid chromatography (HPLC) method for the determination of metronidazole in pharmaceuticals was described and developed. Methods: The reversed-phase HPLC (RP-HPLC) method was developed and the results obtained to determine the form of metronidazole. Chromatographic analysis was performed in HPLC-ultraviolet (HPLC-UV) system with Ion Pac column; Arcus EP-C18; 5 ?m, 4.6 mm× 250 mm, with acetonitrile: triethylamine 30:70 (v/v)+0.5 M potassium dihydrogen orthophosphate buffer at pH 4.5 as mobile phase, at a flow rate of 1.0 ml/min. UV detection in HPLC system was performed at 310 nm. Results: The method was validated for accuracy, precision, specificity, linearity, and sensitivity. The retention time for the metronidazole was 9.9 min. Calibration plots were linear over the concentration ranges 1–5 ?g/L for the metronidazole. The limit of detection was 0.115 ?g/ml and the limit of quantitation was 0.437 ?g/ml. The accuracy of the proposed method was determined by recovery studies and found to be from 93.3% to 100%. Conclusion: Commercial tablet formulation was successfully analyzed using the developed HPLC-UV method that has been validated; accuracy, precision, and specificity were found to be within the acceptable limits. Moreover, results obtained by the suggested methods showed no significant difference between the results obtained from the suggested method.
Keyword :
Detection limit, metronidazole drug, micro-high-performance liquid chromatography, quantification limit, statistical analysis