RP-HPLC ASSAY METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF DILOXANIDE FUROATE AND ORNIDAZOLE IN TABLETS
Keywords:
RP-HPLC, Diloxanide furoate, Ornidazole, Method development, ValidationAbstract
Objective: To develop an accurate, precise and linear Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method for simultaneous quantitative estimation of Diloxanide furoate and Ornidazole in tablets and validate as per ICH guidelines.
Methods: The optimized method uses a reverse phase column, Waters Symmetry C18 (250 X 4.6 mm; 5μ), a mobile phase of potassium dihydrogen ortho phosphate buffer (20 mM, pH2.3): acetonitrile in the proportion of 40:60 v/v, flow rate of 1.0 ml/min and a detection wavelength of 230 nm using a UV detector.
Results: The developed method resulted in Diloxanide furoate eluting at 5.85 min and Ornidazole at 2.85 min. Diloxanide furoate exhibited linearity in the range 22.5-67.5μg/ml, while Ornidazole exhibited linearity in the range 15-45μg/ml. The precision is exemplified by relative standard deviations of 1.58% for Diloxanide furoate and 1.53% for Ornidazole. Percentage Mean recoveries were found to be in the range of 95â€105 by percentage method during accuracy studies.
Conclusion: A rapid, simple, accurate, precise and linear RP-HPLC method was developed for simultaneous quantitative estimation of Diloxanide furoate and Ornidazole in tablets and validated as per ICH guidelines. Hence it can be used for the routine analysis of Diloxanide furoate and Ornidazole in tablets in various pharmaceutical industries.
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