STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF MITOMYCIN AND FLUOROURACIL BY USING UPLC
Keywords:Mitomycin, Fluorouracil, UPLC, Development, Validation
Objective: The current investigation was pointed at developing and progressively validating novel, simple, responsive and stable UPLC method for the measurement of active pharmaceutical ingredients of Mitomycin and Fluorouracil.
Methods: A simple, selective, validated and well-defined stability that shows isocratic UPLC methodology for the quantitative determination of Mitomycin and Fluorouracil. The chromatographic strategy utilized Inertsil ODS column of dimensions 250x4.6 mm, 5 micron, using isocratic elution with a mobile phase of acetonitrile and 0.1 percent formic acid (70:30). A flow rate of 1 ml/min and a detector wavelength of 255 nm utilizing the PDA detector was given in the instrumental settings. Validation of the proposed method was carried out according to an international conference on harmonization (ICH) guidelines.
Results: LOD and LOQ for the two active ingredients were established with respect to test concentration. The calibration charts plotted were linear with a regression coefficient of R2>0.999, means the linearity was within the limit. Recovery, specificity, linearity, accuracy, robustness, ruggedness were determined as a part of method validation and the results were found to be within the acceptable range.
Conclusion: The proposed method to be fast, simple, feasible and affordable in assay condition. During stability tests, it can be used for routine analysis of production samples and to verify the quality of drug samples during stability studies.
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