Method Development And Validation Of Metronidazole In Bulk And Marketed Dosage Form
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Abstract
Development and Validation of a High-Performance Liquid Chromatographic Analytical Procedure for Determining of Metronidazole in a bulk and marketed dosage form is described in this paper. The Separation was made with a C18 Symmetry (4.6 X 150mm, 5μm) Column at ambient temperature, with isocratic mode and mobile phase Phosphate Buffer pH 2.8 : Acetonitrile 35:65 v/v. Eluent was monitored at 284 nm and the flow rate was 1.0 ml/min. Metronidazole was effectively separated with retention time (RT) of 5.1min. Within the selected chromatographic conditions the method was validated for Analytical Parameters:- Specificity, Linearity, Precision, Accuracy, and Limits of Detection and Quantitation. The Calibration curves were linear in the concentration range of 2-20 µg/ml for Metronidazole, and the Regression was found to be 0.997 respectively (NMT 0.999) for Metronidazole. The % recovery for 50%, 100% and 150% accuracy level of Metronidazole was found to be within the range of 99.13-100%. This Analytical Procedure is applicable for the Quality Control of drug formulations.
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References
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