ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ORNIDAZOLE IN TABLET DOSAGE FORM BY ZERO ORDER UV SPECTROSCOPY
Abstract
Objective: To develop and validate two simple and cost effective spectrophotometric methods for the determination of Ornidazole (OND) in pure form and in pharmaceutical tablet dosage form.
Methods: Single point standardization method was used for quantitative estimation of OND. In method 1 absorbance was measured at 311 nm (λmax of OND in methanol) using methanol as a solvent system and in method 2 absorbance was measured at 277 nm (λmax of OND in 0.1 N HCl) using 0.1 N HCl as the solvent system.
Results: The two methods obeyed Beer's law in the concentration range of 3-18 µg/ml (methanol) and 10-35 µg/ml (0.1 N HCl) respectively. The methods were validated for parameters such as linearity, accuracy, and precision, limit of detection (LOD), limit of quantification (LOQ), robustness and ruggedness as per ICH guidelines.
Conclusion: The developed methods were used for determining the content of OND in commercial tablets. The proposed methods were thus found to be suitable for quantitative estimation of OND in bulk and tablet formulation without any interference of the excipients and can be employed for quality control of Ornidazole in tablet dosage form.
Keywords: Ornidazole, Validation, Single point standardization, ICH guidelines
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References
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